Diamond

MaxCyte

MaxCyte is a leading provider of cell-engineering platform technologies that are driving the next-generation of cell-based therapies and making a meaningful difference for patients. The Company's technology is employed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte has granted 13 strategic platform licenses to leading cell-based therapy developers. Through 2020, MaxCyte has granted licenses for more than 140 cell therapy programs, with over 100 licensed for clinical use. Our Flow Electroporation® technology and next-generation ExPERT® platform enable our partners to accelerate, streamline, and improve the drug development process from the early stages of research to commercialization. MaxCyte was founded in 1998 and is headquartered in Gaithersburg, Maryland, U.S.

PTC Therapeutics

PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, on Twitter at @PTCBio, and on LinkedIn.

Sartorius

The Sartorius Group is a leading international partner of the biopharmaceutical industry and the research sector. We are helping biotech scientists and engineers across the entire globe to develop and manufacture medications from the first idea to production. So more people will have access to better medicine.
Sartorius offers the Nutristem® and 4Cell® Nutri-T range of serum-free, xeno-free media for stem cells (MSCs, iPSCs, and ESCs) and T cells, which have become the gold standard in  research and clinical applications, helping to advance stem cell and lymphocyte based therapies.
Sartorius supplies additional related products for stem and T cell culture, including animal component-free freezing media, xeno-free attachment solutions and animal component-free cell dissociation solutions.

Thermo Fisher Scientific

As the world leader in serving science, Thermo Fisher Scientific is uniquely positioned to provide the quality materials, services and support need to accelerate the pace of advanced therapy development. We understand the complexity of this rapidly-evolving industry and have made significant investments in cGMP raw material manufacturing and drug product manufacturing capabilities to provide innovative end-to-end solutions- from the acquisition of Brammer Bio to investing to expand our critical raw material manufacturing facilities. Partner with us to access the high-quality materials, services, and support you need from discovery to clinical research and commercial cell and gene manufacturing. Through our Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab services, Patheon, and Gibco brands, we offer an unmatched combination of innovative technologies, manufacturing, and distribution capabilities.

Viralgen

Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners, combining decades of technology and drug development experience in multiple platforms to support best-in-class service offerings to the gene therapy market.

Viralgen was created in 2017 in response to the unmet need for manufacturing of gene therapies. Our goal was to help broaden the access to these life-saving therapeutics and contribute to the advancement of health and human welfare around the world.

We specialize in the production of rAAV viral vectors. Our optimized facilities in San Sebastian, Spain, maximizes throughput and efficiency of our proprietary Pro10TM suspension manufacturing platform. This enables industry-leading scalability, reproducibility, and speed to market.

Through our superior technology platform, we deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimize the cost-of-goods and accelerate clinical development and commercialization of life-saving genetic medicines.

Platinum

AVROBIO

AVROBIO’s mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease. AVROBIO is powered by the plato™ gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit our website, and follow us on Twitter and LinkedIn.

Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company.  Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality.  Forge has a 175,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as its headquarters.  The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing.  By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

Labcorp

Labcorp Drug Development, formerly Covance, is committed to helping you transform the future of healthcare by bringing promising cell and gene therapies to more patients. Our dedicated cell and gene therapy leaders—supported by a multi-disciplinary team of scientific, operational, medical and regulatory teams—can provide comprehensive and strategic insights for more efficient movement and reduction of risk across critical milestones of your entire therapeutic development journey. No matter where you are or where you intend to go, we’re here to provide the global infrastructure you need combined with the personalized experience you deserve. Labcorp Drug Development is part of Labcorp, a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Learn more about our comprehensive cell and gene therapy solutions at: www.DrugDevelopment.Labcorp.com/CGT. 

Orchard Therapeutics

At Orchard Therapeutics, our vision is to end the devastation caused by genetic and other severe diseases. We aim to do this by discovering, developing and commercializing new treatments that tap into the curative potential of hematopoietic stem cell (HSC) gene therapy. In this approach, a patient’s own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease in a single treatment.

In 2018, the company acquired GSK’s rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Today, Orchard is advancing a pipeline spanning pre-clinical, clinical and commercial stage HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. 

Oxford Biomedica

A leading, fully integrated, cell and gene therapy group focused on developing life-changing treatments for serious diseases, Oxford Biomedica is your partner of choice for viral vector development scale-up, analytics and GMP processing.

Leverage our expertise and state-of-the-art bioprocessing facilities and purpose built laboratories to help to achieve commercialisation of your viral vector-based products.

Using LentiVector®, our sector leading lentiviral vector platform, Oxford Biomedica develops in vivo and ex vivo products both in-house and with partners, including with Novartis, Bristol Myers Squibb, Sio Gene Therapies, Orchard Therapeutics, Santen, Beam Therapeutics, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations.

Additionally, Oxford Biomedica has a 3-year master supply and development agreement with AstraZeneca for large-scale manufacturing of the adenoviral based COVID-19 vaccine, AZD1222.

Discover how we drive credible science to help you realise incredible results - visit www.oxb.com or email partnering@oxb.com.

 

REGENXBIO Inc.

REGENXBIO Inc. is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Our gene therapy product candidates are designed to deliver functional genes to address genetic defects in cells, enabling the production of therapeutic proteins or antibodies that are intended to impact disease. Through a single administration, gene therapy could potentially alter the course of disease significantly and deliver improved patient outcomes with long-lasting effects.  We have developed a broad pipeline of gene therapy programs using our NAV® Technology Platform to address genetic diseases through two modalities: AAV-mediated antibody delivery and monogenic gene replacement. We believe this platform forms a strong foundation for our current programs and with our ongoing research and development, we expect to continue to expand the platform.

SGS

We are SGS - the world’s leading inspection, verification, testing and certification company. SGS boasts a wealth of global health science expertise, supporting you every step of the way as you deliver first-class, fully compliant biopharmaceutical, pharmaceutical drugs and medical devices.

SGS Health Science has one core mission: improving patient health by safeguarding the quality and efficacy of medicines. Our first-class facilities and ongoing commitment to quality helps organizations build a healthier future. With over 35 years’ experience SGS offers an integrated CRO network of biopharmaceutical development and testing solutions to ensure compliance whilst accelerating drug development timelines.

SGS Glasgow is the global centre of excellence for Biosafety. We help clients satisfy regulatory requirements through a comprehensive range of biosafety services such as: virology, cell and molecular biology, microbiology and electron microscopy. The Biosafety services we provide demonstrate to health authorities that the biologics manufacturing is free of potential contaminants.

uniQure

uniQure is delivering on the promise of gene therapy – single treatments with potentially curative results. We are leveraging our modular and validated technology platform to rapidly advance a pipeline of proprietary and partnered gene therapies to treat patients with CNS, liver/metabolic and cardiovascular diseases

WuXi Advanced Therapies

WuXi Advanced Therapies, a global Contract Testing Development and Manufacturing Organization (CTDMO), is the advanced therapies business unit of WuXi AppTec and offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies for customers worldwide. Our technologies, automation platforms and service solutions advance pre-clinical research and accelerate the timeline to GMP manufacture, while integrated GMP manufacturing and testing platforms reduce time to market, maintaining high titres, high levels of quality assurance and full regulatory compliance. Ultimately, our complete end-to-end solutions support pioneering companies to deliver breakthrough cell and gene therapies to the patients who need them.

Gold

Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life-changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector. With over 400 experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation. The Cell and Gene Therapy Catapult works with Innovate UK. For more information, please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.

 

Center for Breakthrough Medicines

Center for Breakthrough Medicines (CBM) is an Advanced Therapy CDMO dedicated to addressing the challenges with bringing breakthrough therapies to patients. CBM offers pre-clinical through commercial manufacturing capabilities spanning process development; plasmid DNA, viral vector and cell therapy production; and a full suite of testing and analytical capabilities. Through a single-source, end-to-end solution, CBM accelerates time to market without compromising quality. 

CEVEC

CEVEC is a leading provider of high-performance cell technology for the manufacturing of advanced biotherapeutics.


With the ELEVECTA® Technology, CEVEC offers a unique solution for large-scale production of AAV vectors using helper virus-free inducible producer cell lines with all necessary components stably integrated into the cell. The technology is based on suspension cells and does not require any expensive transfection reagents nor cGMP plasmids. CEVEC’s CAP® Ad Technology is the ideal production platform for RCA-free Adenoviral vectors. Based on human suspension cells, it allows for a robust manufacturing process, easy scale-up from research grade to industrial volumes and thus opens the way for various applications, from gene therapy to vaccine production.

Cytiva

Cytiva is a global life sciences leader dedicated to advancing and accelerating therapeutics. Cytiva is a trusted partner to customers that undertake life-saving activities ranging from biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.

DiNAMIQS

DiNAMIQS is a Contract Development and Manufacturing Organization (CDMO) revolutionizing gene therapy manufacturing and analytics. Based in Central Europe’s biotechnology hub Bio-Technopark Schlieren-Zürich, our state-of-the-art facility provides a comprehensive range of manufacturing services, process development, quality control and analytics solutions to support and optimize the most promising gene therapy projects. With our innovative customized business interaction solutions, DiNAMIQS accelerates time to the clinic for its partners while reducing cost and risk. Our facility offers potent genetic medicine delivery vectors including high quality recombinant adeno-associated viral (AAV) vector manufacturing suitable for both in vitro and in vivo R&D applications up to 50L scale. Our highly skilled team has demonstrated success in biomanufacturing processes with more than 20 years’ experience in the field. DiNAMIQS is currently building a GMP-compliant facility that can produce viral vectors at 500L scale.

Genethon

Genethon, created by the AFM-Telethon, has the mission to make innovative  gene therapy treatments available to patients affected with rare genetic diseases. To meet this challenge Genethon has assembled the technical and human resources needed to accelerate the medical application of scientific discoveries arising from fundamental research. Strong translational research programs engage multi-disciplinary teams and are supported by a first rate technological platform and cGMP facility

The pipeline of Genethon includes products currently in international clinical trials and at preclinical stages, for immune deficiencies, muscular dystrophies, ocular and liver diseases. These products are developed either with Genethon as sponsor, or in partnership with private companies and academic institutions.

Genezen

Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide – making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers early-phase process development, GMP lentiviral vector production, retroviral vector production, and analytical testing services, building on the company's expansive knowledge and experience in the industry and working with the nation's leading institutions.

GenScript Biotech

GenScript is a world leader in biotechnology reagent services, providing life sciences services and products to over 200,000 scientists in over 100 countries worldwide. Established in 2002 in New Jersey, United States, the company was one of the first to commercialize gene synthesis as well as establish fully integrated capabilities for custom peptide synthesis, complex protein expression and engineering, custom antibody development and engineering, in vitro/in vivo pharmacology, as well as a variety of other research-focused catalogue products.
 
After almost two decades of rapid growth, the company has expanded its business in recent years into the fields of immunotherapy, CDMO and microbiology to further its core mission of making people and nature healthier through biotechnological innovation.
 
With global support from its loyal customers and over 2600 employees located across the globe, GenScript continues to strive towards their vision of being the most reliable biotech company in the world, in service of a better and healthier future.

Human Gene Therapy

Established in 1990, Human Gene Therapy is the leading peer-reviewed journal publishing exceptional, multidisciplinary research embracing all aspects of gene therapy - from basic research to new technologies to clinical development. In 2020 the Journal marked three impressive decades by unveiling a dramatic new redesign and a renewed editorial mission. Human Gene Therapy serves as the Official Journal of ESGCT.

InnovaVector

InnovaVector is a CDMO operator that specializes in the production of AAV vectors. We have ~20 years history of providing clients over 3000 R&D grade AAV vectors for research and preclinical studies for all major serotypes. We routinely solve our client’s vector or plasmid design requirements.

InnovaVector is expanding operations to provide material for phase I/II clinical trials, when our new state of the art GMP facility comes online in Q1 2023.

Our highly experienced scientific team with extensive cGMP background and broad AAV knowhow has helped us build an excellent reputation in AAV gene therapy world.

We bring Client’s innovative clinical idea to life – through AAV!

InnovaVector is a lively international working community with rapidly expanding career opportunities, that people aspire to work for. Located in subtropical Campania-region in Pozzuoli (Naples) on Mediterranean seashore and surrounded by ancient architectural recoveries, we provide modern healthcare solutions using AAV Gene therapy.

MeiraGTx

MeiraGTx (Nasdaq: MGTX) is a vertically integrated, clinical stage gene therapy company with six programs in clinical development and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, and a transformative gene regulation platform technology which allows tight, dose responsive control of gene expression by oral small molecules with dynamic range that can exceed 5000-fold. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring, and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: ocular, including inherited retinal diseases and large degenerative ocular diseases, neurodegenerative diseases and severe forms of xerostomia. Though initially focusing on the eye, central nervous system, and salivary gland, MeiraGTx plans to expand its focus to develop additional gene therapy treatments for patients suffering from a range of serious diseases.

Resolution Therapeutics

Resolution Therapeutics is a biotechnology company developing macrophage cell therapies for chronic liver disease. Founded in 2019 by Professor Stuart Forbes and Professor John Campbell from the University of Edinburgh in collaboration with Syncona, the company is pioneering the development of macrophages to treat inflammation and resolve fibrosis.

The company’s lead product is an autologous engineered macrophage therapy designed to treat liver cirrhosis. Chronic liver disease is the only chronic disease still on the rise in western countries, affecting millions of people worldwide. For patients with end-stage liver disease (cirrhosis) the only therapeutic option is liver transplantation, a complex surgical procedure limited by complications and a shortage of donors.

Synthego

Synthego is a leading provider of genome engineering solutions. The company’s product portfolio includes software and synthetic RNA kits designed for CRISPR genome editing and research. With next-generation informatics and machine learning, Synthego’s vision is to bring precision and automation to genome engineering, enabling rapid and cost-effective research with consistent results for every scientist.

TATAA Biocenter

TATAA Biocenter is a bioanalytical services company at the nexus of molecular biology, bioinformatics and high-throughput analysis, advancing research, clinical trials and diagnostic development. We lead the nucleic acid analysis market with proprietary techniques engineered to support your research needs more efficiently and precisely. We support academic and industry partners with assay design, workflow optimization and validation, quality control, multiomics analysis, data analysis, reporting, tech transfer, trainings, and sample management.

Yposkesi

YPOSKESI, based in Corbeil-Essonnes, near Paris (France), is one of the largest European Contract Development and Manufacturing Organizations dedicated to the development and production of gene and cell therapy treatments. The broad expertise of YPOSKESI covers the production of Lentivirus & AAV viral vectors based on transfection processes, for pre-clinical development and clinical trials in compliance with the standards of Good Manufacturing Practice regulations. YPOSKESI benefits from the 30 years viral vector expertise of its long-standing partner, GENETHON, a major player in gene therapies for rare disease.

 

In addition, YPOSKESI has an experienced and efficient team of nearly 190 experts in Bioproduction, Quality Assurance, Quality Control, Project Management and Process Development, operating in a 5,000m2 (approx. 53,819 sq ft) modern GMP facility. YPOSKESI is also significantly investing in the development of innovative technologies for large-scale cost-effective manufacturing of these highly complex Advanced Therapeutics Medicinal Products. YPOSKESI plans to extend its production capacity by 2022, with an additional building including two suites dedicated to commercial manufacturing activities with a total of 10,000 m² (approx. 107639 sq ft) space.

 

By forging a solid industrial partnership with the South-Korean SK group, its majority equity shareholder, YPOSKESI reinforced its industrial strategy based on the technological expertise of SK pharmteco, the US SK’s affiliate, complementing that of YPOSKESI, and its solid experience in international manufacturing as a contract manufacturing organisation (CMO).

 

Silver

Aldevron

Founded in 1998, Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients worldwide rely on Aldevron-produced plasmid DNA, RNA, gene editing enzymes and more for biological research projects from discovery to clinical trials and commercial applications. These efforts help accelerate development of treatments for diseases such as cancer, infectious disease, pediatric disorders and rare diseases.  

Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Our mission is to be a partner in the development of medicines that improve patients’ lives while serving clients, employees, and the community, while constantly looking for new and better ways to give researchers the products and services they need.  

Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world, located in Fargo, North Dakota, which serves as company headquarters, with additional production facilities in Madison, Wisconsin, and Lincoln, Nebraska. 

Alfa Wassermann

Zonal Ultracentrifugation Solutions

AWST provides zonal ultracentrifugation solutions that efficiently and reliably separate viruses, virus like particles and viral vectors for the development and manufacture of vaccines, gene therapies, and other bio-products.  From research scale to full production, our patented core technology makes linear scalability possible with no revalidation or compromise of yield and purity.  AWST ultracentrifugation systems reliably remove empty capsids to undetectable levels.  With the addition of the AWST Automated Fluid Handling (AFH), customers now have a system that fully automates and standardizes the critical process of fluid filling and fractionation in a self-contained mobile work station. 

 

Andelyn Biosciences

Andelyn Biosciences is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 16+ production suites for customization of new programs and tech transferred programs as of 2H 2022, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients.

ArcticZymes Technologies

ArcticZymes Technologies ASA is born from the unique conditions in the Arctic and our labs in Tromsø (Norway), we have been developing and producing cold-adapted enzymes for more than 30 years.

 

Our high-quality enzymes are an integral part of molecular research and diagnostics, either as stand-alone enzymes or as components of kits. In therapeutics such as gene therapy and vaccine production our enzymes aide the optimization of manufacturing processes.

 

All our products are manufactured to ISO 13485 standards and meet all REACH requirements. The unique features of our premium enzymes are accompanied by our dedication to quality, and a no-compromises approach to collaborate with our clients and partners.

 

ArcticZymes Technologies is trusted by leading molecular research kit manufacturers, diagnostic assay developers, contract manufacturers, and therapeutic companies around the world.

 

Aseptic Technologies

ASEPTIC TECHNOLOGIES manufactures innovative aseptic production equipment, designed to provide safer & easier aseptic filling operations.

The AT-Closed Vial® is provided ready to fill with its stopper secured in place, and sterilized by gamma irradiation.  The filling is performed by a special needle piercing the stopper, which is then immediately heat-resealed by laser and capped. The drug product is thus never in contact with the environment.

The AT-Closed Vial® ensures uncompromised Container Closure Integrity at -80°C and in vpLN2.

AskBio

At Asklepios BioPharmaceutical (AskBio), we are making history with every clinical advancement and aspire to turn hope into cures by unraveling new possibilities for genetic medicine. We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform.

AskBio is headquartered in Research Triangle Park, North Carolina, a thriving biotechnology hub with nearly 600 life science companies, and has additional research and development facilities in Edinburgh, Scotland, and Paris, France, and gene therapy manufacturing in San Sebastian, Spain.

Started in 2001, we are on a never-ending quest to advance genetic technology and life-saving gene therapy. We are singularly focused on a goal to erase genetic disease. It is an audacious goal that will not be accomplished by us alone, but it is one to which we have already made significant contributions.   

Almost 40 years ago, AskBio’s scientific co-founder, Jude Samulski, PhD, was the first to demonstrate that adeno-associated virus (AAV) could be cloned for therapeutic purposes. His groundbreaking research propelled the most exciting field in medical research today. His work inspires our world-leading gene therapy platform that is bringing new therapeutics to market and resulting in new methods for lowering the cost of delivery.

Asphalion

Asphalion is an international Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid and Munich. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, through to registration and post-commercialization phases. Since the company was founded in 2000, we have consistently grown and now have a team of over 80 employees with backgrounds in all areas of life sciences. Our consultants are experts in their fields and are in direct contact with European agencies for the implementation of new regulatory standards. We provide global services and work for hundreds of clients from around the world. Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise.
Services:
• Regulatory and Scientific Strategy during Development
• Medical and Scientific Writing
• Global Submissions
• eSubmission and RIM
• Life-Cycle Outsourcing
• Pharmacovigilance
• Promoting the marketing registration of Medical Devices: Classification strategy, CE Marking and compilation of technical file. 

Barkey GmbH & Co. KG

Barkey is a German family business for medical technology in the field of warming devices. Founded in 1980 by Volker Barkey, Thomas and Christian Barkey together with Armin Nowack and the entire staff have led the company to worldwide awareness in the hospital and blood bank sector as well as in cell & gene therapy research.

Barkey has two main goals: Preventing hypothermia and advancing Cell & Gene research to develop new cancer therapies. For this purpose, Barkey produces various solutions for warming or thawing blood, blood products and cellular materials, infusion solutions, etc. The safety of the samples, the user and, of course, the patient is of priority. Barkey relies exclusively on dry heating systems since the use of open water baths offers a high risk of contamination. This must be avoided both, during the preparation of patient treatment and during the research and production of new therapeutic procedures.

Beckman Coulter Life Sciences

Beckman Coulter Life Sciences is dedicated to developing and providing advanced technologies and equipment for research and discovery to explore new treatment methods. Our products include Liquid Handling and Genomic solutions, Particle Counting and Characterization, Centrifugation and Flow Cytometry, which are implemented in all major areas of Life Sciences such as biology, biochemistry, biophysics, nanotechnology and molecular biology to simplify and automate existing processes in the lab.

Our vision: Advancing science through discovery

Our mission: Delivering innovative and trusted scientific solutions across the globe

BioAgilytix

BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across a number of industries and disease states.

BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e., product release testing, stability testing, etc.) BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.

BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity and regulatory compliance through all phases of clinical development. BioAgilytix is a trusted partner to many top global pharmaceutical and biotech companies.

Biocair

Biocair is a global specialist courier with over 30 years of dedicated experience in the pharmaceutical, biotechnology and life science sectors. Specifically, we provide dedicated, specialised logistics services – both the systems and the people – for the scientific sector and our services are the most comprehensive of its kind available on the market.

The company has built up a unique, client-centric approach by employing scientists in front- line logistics positions and assembling a team of best-in-class industry experts in quality, cold chain and regulatory compliance amongst others. Biocair focuses on providing the most comprehensive time-sensitive and temperature-controlled logistics services available whilst delivering flexible, tailored, cost effective solutions to all clients.

The Biocair network spans more than 850 locations in over 160 countries across Europe, Africa, Asia and the Americas.

c-LEcta

c-LEcta – for tomorrow’s industry

c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the pharma and food industries. c-LEcta’s proprietary GMP endonuclease DENARASE® and the associated ELISA kit are widely applied in the manufacturing of viral vectors for gene/cell therapies and vaccines, both on clinical and commercial scale. DENARASE® is manufactured under EU GMP conditions in Germany and comes with extensive regulatory documentation (including US FDA Drug Master File and compliance with EXCiPACT/ANSI NSF 363). c-LEcta is based in Leipzig and currently employs more than 100 people.

CeGaT

CeGaT is a global provider of genetic analyses for a wide range of medical, research, and pharmaceutical applications.

Founded in 2009 in Tübingen, Germany, the company combines state-of-the-art sequencing technology with medical expertise – with the aim of identifying the genetic causes of diseases and supporting patient care. For researchers and pharmaceutical companies, CeGaT offers a broad portfolio of sequencing services and tumour analyses. CeGaT generates the data basis for clinical studies and medical innovations and drives science forward with its own insights.

The owner-managed company stands for independence, comprehensive personal customer service, and outstanding quality. CeGaT's laboratory is accredited according to CAP/CLIA, DIN EN ISO 15189, and DIN EN ISO/IEC 17025 and thus meets the highest international standards. To obtain first-class results, all processes are carried out in-house under scientific supervision.

Cellex

Many Tasks – One Name: Cellex Cell Professionals GmbH

Cellex is offering the complete spectrum of services in the field of cell and gene therapies for partners worldwide. Our scope is R&D, clinical as well as commercial manufacturing and testing.

Cellex started its operation in the very first field of cell therapy with the Cellex Collection Center in 2001 offering stem cell collections from unrelated donors for leukemia patients. Meanwhile Cellex runs the largest and with regard to allogeneic donations most experienced centers worldwide.

Today focused on CGT, Cellex manufactures as a CDMO in two state-of-the-art GMP facilities different cell products (intermediates, final products) using various techniques (separation, genetic modification using viral vectors, gene editing using CRISPR Cas, expansion and cryopreservation); all processes are adapted to customers` needs. Based on profound experience in EU and FDA regulations, Cellex stands for a successful tech transfer of processes from US to Europe and the other way around.

Cellex runs a registry with a highly diverse donor pool; together with the Cellex registry network we support R&D, clinical or commercial requests with customized cell products (leukopak, bone marrow, whole blood ….).

Centralized management using secure and efficient IT solutions and well established transport solutions round off the comprehensive Cellex portfolio.

Charles River Laboratories

The journey to market for a cellular or novel gene therapy is challenging given the unique and high specialized nature of each individual program, so it is crucial to choose a partner with proven experience developing these types of treatments and navigating the regulatory hurdles often associated with them.  With over 70 years of experience, Charles River has a unique and comprehensive portfolio to support the development and execution of cellular and gene therapy programs from animal model selection to discovery and safety evaluations through to clinical and CMC testing support with expertise in a wide range of therapeutic areas. Our facilities in the United States, Canada, Britain, Finland, Netherlands, and Germany form a global scientific and regulatory network, allowing us to provide our clients with flexible, comprehensive solutions to optimize results and achieve milestones in order to make it to market on time. 

ChemoMetec A/S

ChemoMetec is a leading manufacturer of cell counting and analysis equipment. We specialize in developing and producing high-precision instrumentation that delivers consistent data for thousands of customers across segments including biotech, pharma, and academia.

Our NucleoCounter® instruments dominate the cell therapy space. They are the most robust and consistent cell counters on the market. What’s more, they are standardized for easy deployment across departments, and they are 21 CFR Part 11-ready, enabling you to fully integrate single or multiple instruments into your existing IT networks.

Designed, manufactured, and tested in Denmark, we build our instruments and consumables with quality materials and dedicated expert workmanship.

Clean Cells

BIOSAFETY TESTING
A full range of regulatory tests in compliance with GLP and cGMP, with more than 200 qPCR tests available. Capability to develop and validate innovative, sensitive, specific and robust tests in accordance with ICH Q2 R1.
 
GMP PRODUCTION and STORAGE
Production of Eucaryotic and Procaryotic cell banks, Viral banks and Storage in liquid nitrogen or -80°C.
 
ASSAY DEVELOPMENT
Production of cell models which express molecules of interest.
Transfection, cloning, selection, amplification.
Analysis in vitro of the cell responses: measurement of viability, proliferation, phenotype, specific functions (ex. ADCC, apoptosis, CDC), interferon activity.
Development and validation of qPCR tests: detection quantification of pathogens or contaminants, residual DNA, determination of sites of insertion of a transgene, gene copy number.
Development and validation of virus titration method. 
Detection and validation of recombinant competent replication tests (rcAAV,RCL) for gene therapy.
 
ADVANCED MEDECINE THERAPY MANUFACTURING FOR PHASE I/II
GMP manufacturing platform for bacteriophages and cell therapy products for phase I / II clinical trials.

Eurogentec

The Bio-Manufacturing business unit is a cGMP accredited Contract Manufacturing Organization (CMO) that produces recombinant proteins and plasmids from microbial fermentation and IVT-RNA for clinical and commercial phases.
Eurogentec provides a wide range of services: process transfer and development, cGMP manufacturing, Quality Control, bulk release.
 
In 2020, Eurogentec launched a 1500L commercial line.
 
Plasmid: Cost-effective manufacturing of GMP starting material or injectable API pDNA.
rProtein: Significant experience in the protein production from Yeast (P.pastoris, S.cerevisiae, etc) and bacteria (E.coli).
IVT-RNA: Eurogentec is a pioneer in GMP in vitro transcript RNA. Our new facility can adapt to many different processes including availability of various modifications (co- or post-transcription).
 
With over 20 years of experience as CMO, you benefit from our broad manufacturing experience. Our philosophy is to establish a close partnership with our clients, adapt to their project needs and to provide them with cost and time efficient production processed.

Evotec

Evotec is a life science company with a unique business model focused on providing access to highly effective new therapeutics. The Company leverages its multimodality platform with a unique set of innovative technologies for both proprietary and partnered projects.

 

Exothera

Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development.

FUJIFILM Irvine Scientific

FUJIFILM Irvine Scientific is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. We provide unrivaled service and quality to scientists working in cell therapy and regenerative medicine, assisted reproductive technology and cytogenetics, and bioproduction for commercial manufacturing of biotherapeutics and vaccines.

Our commitment to supporting the biopharmaceutical industry in the successful development and commercialization of human therapeutics and vaccines is evident in the alignment of our technology, support, and supply capabilities to meet and exceed the distinctive requirements of the market. While remaining a uniquely flexible and focused media company for over 50 years, FUJIFILM Irvine Scientific has steadily advanced as a strategic global supplier in support of our customers from early development to commercialization.

GenIbet Biopharmaceuticals

GenIbet Biopharmaceuticals is a GMP biopharmaceutical CDMO offering highly specialized GMP manufacturing and development services. GenIbet core activity is the manufacture and supply of starting materials and Investigational Medicinal Products for use in early-stage drug development, pre-clinical studies and GMP manufacturing for clinical trials.

GenIbet expertise spans over a broad spectra of Biopharmaceuticals development, including recombinant proteins, Vaccines, RNA, Live Microbial Products and Cell and Gene Therapy products. GenIbet’s manufacturing portfolio includes a variety of mammalian, avian and insect cells, microorganisms and Viruses.

As of early 2022, GenIbet is part of Recipharm a leading CDMO, which is currently expanding its well-established capabilities on small molecules from preclinical-to-clinical and commercial approval to include new biological modalities such as viruses, viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Recipharm network on Biologics includes GenIbet, ArrantaBio and Vibalogics.

GenoSafe

GenoSafe provides analytical testing services for the evaluation of quality, safety and efficacy of Gene and Cell therapy candidates including:

· GLP biodistribution, shedding and immunogenicity studies ;

· QC testing, such as viral titration, safety and potency/efficacy testing ;

· GCP bioanalysis of patient samples, including immunogenicity, shedding and gene expression studies.

GenoSafe brings more than 15 years of experience in the development, qualification and validation of key analytical methods for product and sample testing.

Grifols Bio Supplies

Grifols is a global healthcare company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries.

The Bio Supplies Division supplies high-quality biological materials for biotechnology research, clinical trials, and for manufacturing pharmaceutical and diagnostic products.

Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry.

Halo Labs

Halo Labs knows aggregates and particles. The Aura can count and characterize subvisible particles and tell you if they are aggregated drug product, excipients, or external contaminants. A simple, plate-based approach enables low-volume, high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.

JPT Peptide Technologies

JPT provides products and services for all the development phases of next generation immunotherapeutics. With sound knowledge in immunology and peptide chemistry, we offer peptides and peptide pools (PepMix™) for antigen-specific stimulation of cells, humoral and cellular epitope mapping, viral transduction, and development of immunotherapies. 


Thanks to an enhanced production protocol, our peptides are the product of choice for the development of cell therapies such as adoptive cell transfer or dendritic cell pulsing independent if you are aiming for an individualized neo-epitope approach or working with shared and common antigens. 


With our novel transduction enhancer Protransduzin™ the generation of CAR-Ts or TCR-Ts can be streamlined by enhancement of viral transduction in a simple one-step protocol.  Humoral immune response is addressed with our PepStar™, high-content microarrays for seromarker discovery and multiwell microarrays for profiling up to 20 samples.

Kriya

Kriya is a fully integrated gene therapy company on a mission to revolutionize how gene therapies are designed, developed, and manufactured – with a goal of improving speed to market and reducing cost. The company leverages its proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer products with the potential to transform the treatment of a broad range of diseases. Kriya’s team includes scientific pioneers with decades of experience in product development, complex manufacturing, and computational engineering.

The company has established an ecosystem for delivering best-in-class technologies and medicines, with core business units in technology, manufacturing, R&D, and therapeutics. Kriya’s product pipeline addresses diseases of high unmet need with therapeutic area divisions in ophthalmology, oncology, rare disease, and chronic disease, each led by industry veterans with a track record of advancing products from concept through commercialization. Built upon this foundation, Kriya achieves the scale needed to drive transformational improvements in the engineering, production, and translation of gene therapies. 

Lonza

At Lonza, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges.

Together, let’s bring your next medicine to life.

Merck

We are Merck KGaA, Darmstadt, Germany the vibrant science and technology company. Science is at the heart of everything we do, it drives the discoveries we make and the technologies we create. Our products and services help you safely and efficiently develop and manufacture cell and gene therapies.

Our 30+ years of global expertise integrating leading manufacturing technologies with process development, scale-up, analytical development, and biosafety testing is here to help you accelerate your path to cures. Draw on our experience to bring your cell and gene therapies to life.

Miltenyi Biotec

Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. Our innovative tools support research at every level, from basic research to translational research to clinical application. Used by scientists and clinicians around the world, our technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, and cell culture. Our more than 25 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer. Today, Miltenyi Biotec has more than 2,000 employees in 28 countries – all dedicated to helping researchers and clinicians make a greater impact on science and health.

 

Mission Bio

Mission Bio is a life sciences company that enables comprehensive characterization of your cell and gene therapy candidates for safer and more effective therapeutics. The company’s Tapestri Platform empowers developers to accurately assess multiple genotypic attributes in a single assay, including on- and off-target gene editing, zygosity, chromosomal aberrations, transduction efficiency, and vector copy number— in 1000s of individual cells. The platform’s robust multi-omics capability enables DNA and cell-surface proteins to be co-measured in the same cells, providing information on genotype and cell type/ state. Mission Bio partners with biopharma to provide full-service Pharma Assay Development — including experimental design, lab work, and bioinformatic analysis — so you can leverage single-cell analysis in your preclinical, clinical, and commercial efforts.

Myriade

Myriade develops the VIDEODROP, an innovative nanoscale imaging technology. 


Based on the principles of interferometry, the Videodrop makes it possible to measure the size and concentration of biological nanoparticles like lentivirus, adenovirus or retrovirus 

  • in real time (40s) 
  • in a single drop (5µL) 
  • between 80nm & 500 nm 
  • in a concentration range of 10E8 to 10E10 part/ml 
  • without labelling & no purification 
  • on viscous & complex samples

Videodrop measures the physical titer of viral vector solutions, so it allows to: 

  • Continuously monitor bioproduction processes thanks to its rapidity of measurement (40s) 
  • Work on real samples at any stage of the bioproduction in a non-denaturant way 
  • Control the yield of vector production after harvesting, Purification, or Concentration steps 
  • Quickly identify lot-to-lot variations  

Providing linear results compared to p24 ELISA, VIDEODROP is suitable for "at-line" characterization of lentiviral vectors and in-process controls. 
 

NHSBT

NHS Blood and Transplant is a national organisation within the NHS dedicated to saving and improving lives.


Our Cellular and Molecular Therapies function offers broad experience and expertise in the provision and manufacture of cell and gene therapies through our national network of GMP grade and MHRA licensed facilities.
NHSBT partner with academic, commercial and NHS organisations supporting novel cell and gene therapy programmes from concept through to clinical trial, operating a ‘not for profit’ model. 


We welcome expressions of interest for partnerships with organisations striving to develop the future of medicine in the advanced therapies space.

PackGene Biotech

PackGene is a leading CRO and CDMO company providing AAV-based gene therapy solutions to institutions and biotech companies.  Ever since it was founded in Massachusetts in 2014, PackGene has been focused on providing expertise, reliability, scalability, and efficiency in AAV packaging services and AAV manufacturing.

PackGene has a 90,000+ ft2 custom-designed cGMP facility, dedicated to plasmid DNA and AAV viral vector manufacturing, from GLP grade to GMP grade. We are experts in process development, scale-up as well as analytical testing.  This is underpinned by a well-established safety framework, a track record of quality and compliance, a robust supply chain and access to skilled scientists.

Our goal is to collaborate with biotech companies and institutions to accelerate gene therapy programs from early discovery, preclinical stage through clinical, and on to commercial manufacturing.

Pall Corporation

Pall Corporation provides critical filtration, separation and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe. Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers' biggest fluid management challenges. And in doing so advance health, safety and environmentally responsible technologies. Together, our Life Sciences and Industrial teams serve a diverse range of customers including biotechnology, pharmaceutical, medical, food and beverage, laboratory, microelectronics, aerospace, fuels, petrochemical, chemical, automotive and power generation industries. Our industry-leading technologies and solutions are at work in countless applications, protecting critical operating assets, improving product quality, safeguarding health, and minimizing emissions and waste.

Paul-Ehrlich-Institut

The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, is a world-renowned scientific institute devoted to improving public health by ensuring the safety and efficacy of vaccines and biomedicines both in Germany and throughout the world. PEI carries out its mission through scientific research and medicinal product regulation. Internationally competitive research is carried out in the fields of virology, microbiology, allergology, immunology, hematology and cell and gene therapy.

PeproTech

PeproTech, part of Thermo Fisher Scientific, specialises in the development and manufacture of high-quality cytokine products for the life-science and cell therapy market. 

With more than 30 years’ manufacturing experience, PeproTech’s range of RUO, Animal-Free and GMP cytokines offers the performance and reliability that you need.

With over 2,000 products, PeproTech has developed and refined innovative protocols to ensure quality, reliability and consistency.

Our mission is to provide the highest quality products and premium support that address the needs and demands of today's scientists and researchers.

We pride ourselves on being a trusted partner within the scientific community.

Please contact PeproTech to request a quote or discuss your research requirements:

Tel: 020 7610 3062 or Email: info@peprotech.co.uk

PlasmidFactory

PlasmidFactory GmbH & Co. KG is a globally active biopharmaceutical company, founded in Bielefeld, Germany, in 2000. The leading contract manufacturing organization (CMO) for plasmid and minicircle DNA has a strong customer base in the fields of cancer research, gene and cell therapy, CAR-T cell development, and vaccination.

PlasmidFactory produces plasmids and minicircles according to client's requirements in modern laboratories with high quality standards.

The company's R&D activities are focused on its core competencies: Production, analysis and storage of plasmid and minicircle DNA. Furthermore, PlasmidFactory co-operates with national and international partners on individual projects, e.g. in the fields of CAR-T cell, AAV production and mRNA production.

Polyplus Transfection

Polyplus-transfection applies its 20 years expertise to the development of novel transfection solutions. Polyplus-transfection is the leading supplier of a key critical component for viral vectors manufacturing for Gene & Cell Therapy. We are proud to provide qualified and GMP-grade transfection reagents suitable from R&D to clinical trial and commercial scale, accompanied by a strong scientific and regulatory support. In addition, we provide a range of effective transfection reagents to deliver most nucleic acids, including DNA and siRNA in vitro and in vivo.

Powered Research

Powered Research is a preclinical CRO specializing in non-GLP ophthalmic models for life science R&D companies. We offer services that range from supporting clients' early research to creating custom ophthalmic models to fit their unique needs. Our offerings include tolerability, efficacy, and pharmacokinetics with fully customizable models for all stages of pre-clinical development.

Progen

The limited availability of accurate & reliable techniques for analytical characterization of AAV vectors is causing obstacles worldwide for laboratories trying to find treatments for genetic disorders. PROGEN is a leading manufacturer and exclusive provider of AAV analytical tools which support the development of safe and efficient gene therapy. Our products include AAV ELISA kits, AAV protein & capsid standards, AAV antibodies and density gradient media. PROGEN‘s AAV ELISA kits and capsid standards are mainly used for capsid titer quantification during analytical characterization, and our exclusive AAV antibodies and VP protein standards serve common methods used for AAV vector manufacturing and characterization, as well as analysis of pre-existing AAV antibodies in patient sera. We strive to understand what scientists need so we can create solutions and ultimately deliver high quality and exclusive AAV products, which solve the challenges within academia, biotech and pharma. Our mission is to help advance new therapies and develop existing research processes safely, quickly and affordably by providing AAV tools along the complete value chain – from basic research, to manufacturing and quality control.

Proteintech Europe

Proteintech manufactures antibodies, immunoassays, HumanKine recombinant proteins and ChromoTek Nanobody-based reagents.

Proteintech’s comprehensive library of original validation data, product-specific protocols, and over 130,000 product citations enables you to publish faster with reproducible results.  

  • Antibodies against over 13,000 human targets
  • Immunoassay kits
  • RUO and GMP HumanKine cytokines and growth factors
  • ChromoTek Nanobody-based reagents
  • Supporting tools and reagents

Browse the full product range at ptglab.com or contact europe@ptglab.com to learn more about our products and promotional offers.

QuickSTAT

For 40+ years, QuickSTAT has been providing the leading pharma and biotech companies 24/7/365 global life science logistics solutions, from R&D, clinical trials through to commercialization.

Our team of logistics experts provide time- and temperature-sensitive shipping of clinical research samples, cell and gene therapies, investigational drugs, clinical trial supplies and vaccines, helping bring new drugs to market.  Strict chain of custody, chain of identity and GDP protocols ensure product integrity and patient safety. QuickSTAT provides customized temperature control solutions and consultation/ procurement of proper packaging—from refrigerated to cryofrozen. Advanced logistics tools provided for managing your supply chain.

Refeyn

Refeyn, the mass photometry pioneer, offers new capabilities to characterise the function, structural composition and dynamics of biomolecules. Refeyn instruments measure the mass of individual molecules directly in solution, quickly and simply revealing the true behaviour of molecules in near-native environments.  The diverse applications of mass photometry include quantitative analysis of sample purity and homogeneity, biomolecular complex assembly and disassembly, the strength and kinetics of molecular interactions, and more. Refeyn was spun out of Oxford University in 2018 to make mass photometry available globally. Its technology has now been rapidly adopted across academia and industry, where it is transforming biomolecular characterisation.  The TwoMP, Refeyn’s mass photometer, brings the technology into everyday laboratory life, enabling molecular measurements with unprecedented speed and simplicity. It uses proprietary technology to detect the light scattered by single molecules in solution, delivering label-free mass measurements over a broad mass range with high precision and exquisite sensitivity.

ReiThera

ReiThera Srl is a Biotechnology Company developing products based on DNA delivery technologies for advanced therapies and genetic vaccines. We provide effective solutions - from early development to final QP release - to support the market of gene-delivery technologies for the prevention and treatment of serious or life-threatening diseases. The laboratories and facilities located in Naples and Rome, are specialized in the isolation and manipulation of wild-type viruses through a) vectorization and b) transgene engineering and offer state-of-the-art technologies and expertise to evaluate the immunological responses to viral vectors. The Company offers a large viral vector manufacturing portfolio supported by a multiproduct cGMP Facility inclusive of filling suite.

Roslin CT

RoslinCT is a leading Cell & Gene Therapy CDMO enabling you to bring your autologous or allogeneic therapy safely to the patient. Based at the Edinburgh BioQuarter, we operate a fully licensed GMP manufacturing facility and have a proven track record in the delivery of cell-based products.

We offer a range of integrated services from technology transfer, process and assay development through to GMP manufacturing, storage, QP certification and batch release of cell-based therapies for clinical trials.

At the heart of RoslinCT is a dynamic, highly experienced team that will understand your goals and will partner with you to get your therapy to market efficiently and effectively.

Samplix

Samplix supports the life sciences and medical research communities with proprietary microfluidics-based solutions designed to deliver the highest-resolution insights into cells and genomes. Our technology encapsulates single mammalian, bacterial or yeast cells, DNA, and other biological material together with assay chemistry. This supports a range of downstream analyses: functional analyses of single mammalian cells, assessments of single-cell enzyme activity, characterization of edits in engineered genes, and even cell incubation. As a leading developer of microfluidics solutions, Samplix stands ready to help researchers reach their goals in areas as diverse as gene and cell therapy, synthetic biology, and molecular engineering.

Sarepta Therapeutics

Sarepta Therapeutics is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

ScaleReady

ScaleReady is a joint venture between Bio-Techne, Fresenius Kabi, and Wilson Wolf. Bringing together proven tools and technologies for cell culture, cell activation, gene editing, and cell processing, ScaleReady provides leading therapeutic developers with the most simple, scalable, and versatile manufacturing platform in the industry. Our platform includes G-Rex® cell culture technology, the Lovo and Cue cell processing systems, and a wide range of GMP proteins, reagents, media, and gene editing technologies. 

SIRION Biotech

SIRION Biotech GmbH is Europe’s leading commercial supplier of viral vector technologies (AAV, LV, AV). Our viral vector know-how enables engineering for a new generation of optimized vectors, in R&D grade as well as clinically-compliant.

We guide our customer through the entire Cell & Gene Therapy value chain – from capsid evolution and clinical vector design to reduce vector dose and improve therapeutic success, to supporting them with our process and development experience and manufacture of high-quality viral vectors for late preclinical applications.

We also offer LentiBOOST®, a highly effective lentiviral transduction enhancer for therapeutic cell types like CAR-T cells and CD34+ hematopoietic stem cells. LentiBOOST® is currently included in more than 20 Phase III and I/II clinical trials.

The company is easily accessible with headquarter in Munich, as well as offices and agents in Boston, Paris, Tokyo, Seoul and Tel Aviv. Commercial arrangements range from fee-for-service and IP-generating collaborations to milestone & licensing arrangements.

Standard BioTools

Standard BioTools manufactures, and markets technologies and life science tools focused on the production and manufacturing of gene and cell therapy products. From sensitive and in-depth single-cell characterization of cell therapy products with single-cell genomics with the C1™ system, to the possibility of monitoring the in-depth phenotype and function of these products with ready-to-use high-dimensional cytometry assays, Standard BioTools accelerates all aspects of the research field within the cell and gene therapy space.

 

STEMCELL Technologies Inc.

At STEMCELL, science is our foundation. Driven by our mission to advance research globally, we offer over 2,500 tools and services supporting discoveries in stem cell research, regenerative medicine, immunotherapy, and disease research. By providing access to innovative technologies such as organoids, gene editing, and specialized media, we’re helping scientists accelerate the pace of discovery.

Stilla Technologies

Stilla Technologies is the multiplex digital PCR company transforming complex genomic data into actionable insights across a wide range of research and clinical applications including gene and cell therapies, cancer and liquid biopsy studies, infectious disease detection, and food and environmental testing. Stilla’s groundbreaking Crystal Digital PCR™ solution, the naica® system, is the industry’s first digital PCR system featuring six fluorescent channels, providing biomedical researchers and clinicians the highest multiplexing and detection capacity available on the market. Stilla has U.S. headquarters in Boston, MA, European headquarters in Paris, France, and strategic distribution and business partnerships in China and throughout EMEA.

Symbiosis

Symbiosis Pharmaceutical Services is a contract development and manufacturing organisation (CDMO) specialising in the GMP manufacture and sterile fill/finish of vials for clinical trials and commercial supply. Regulatory compliance, technical capability and operational flexibility are at its core.

Manufacturing from a purpose-built FDA inspected and MHRA-licensed facility, the CDMO can handle products that require aseptic liquid filling and lyophilisation for a range of complex biologics, viral vectors for use in gene therapies and small molecule drugs.

Offering fast access to manufacturing slots and accelerated release of drug product, Symbiosis is primed to meet demand for small-scale, fast-turnaround drug product sterile manufacturing.

SynGenSys

SynGenSys (Synthetic Genetic Systems) creates product-specific libraries of synthetic genetic parts for next-generation biomedicines and biomanufacturing processes. Our philosophy is simple: all products and production processes are unique. Therefore, core genetic assemblies used for therapy or biomanufacturing should harbour custom synthetic DNA parts and circuits designed to be fit for specific purpose. Our platform technology harnesses years of research and development with bioindustrial partners. We engineer novel synthetic genetic parts from the ground-up, based on bioinformatic analysis of streams of genome-scale information pertinent to the biological system and user-defined design criteria.  

Gene and Cell Therapy: DNA Engineering for Cell Type Specificity and Control. Transfer of therapeutic DNA or mRNA into human cells underpins many new strategies to treat disease.  However, precise targeting and control of gene expression remains a fundamental challenge. Our design systems create novel libraries of cell-type specific promoters with a minimised DNA footprint that provide user-defined control of therapeutic transgene expression.

TAAV

TAAV Biomanufacturing Solutions is advancing gene therapy by offering its synthetic, linear, double stranded DNA, dbDNA, as the new industry standard for transfection-based AAV production. We believe it is a safer, more effective, more scalable and a faster way to manufacture AAV.

Takara Bio Europe

Takara Bio Europe is a leading manufacturer and supplier of molecular and cellular research reagents and services. With over 25 years of experience, our high-quality, innovative tools help to accelerate translational and clinical discoveries from the lab bench to the clinic.

We provide a reliable and consistent supply of reagents, from research to GMP grade. Our products include Cellartis® DEF-CS™ 500 Culture System and RetroNectin® GMP grade. With over 60 clinical trials using our products, they are recognized as worldwide standards for cell and gene therapy protocols.

Alongside our GMP production capabilities, we offer a wide range of genetic engineering and stem cell services. These services include sourcing, gene editing and cell banking. Our experts provide support and ongoing communication at every phase of your project giving you confidence in the success and timely completion of your project.

Unchained Labs

Here’s the deal. We’re all about helping biologics and gene therapy researchers break free from tools that just don’t cut it. Unleashing problem-tackling products that make a huge difference in the real science they do every day. That’s our mantra, our promise and we own it.

Univercells Technologies

Univercells Technologies is a global provider of innovative biomanufacturing technologies to achieve cost-effective viral production from R&D to commercial scales. The company offers a comprehensive technology portfolio leveraging the strengths of process intensification and chaining as a direct answer to the growing demand for viral vectors and viral vaccines. Univercells Technologies is committed to helping customers increase performance with minimized footprint and costs today, while anticipating the needs of tomorrow.

Building upon years of expertise and capitalizing on technology vetted by world leaders, Univercells Technologies was incorporated in Belgium in 2020 with the support of the Univercells group.

VDO Biotech

VDO Biotech Co., Ltd. is a high-tech enterprise dedicated to innovative microsphere technologies and the production of a variety of high-quality microsphere products for global customers. The headquarters of VDO is located in the BioBAY of Suzhou Industrial Park in, China, with ISO9001:2015 certified manufacturing facilities and a total area of facilitates of more than 10,000 square meters. Our dedicated staff is your reliable partner for the solution of any microsphere-related applications.

VDO Biotech is deeply engaged in the large-scale microsphere production and application for in vitro diagnostic. We not only provide microspheres of uniform and controllable particle size, nano-sized & micro-sized microspheres with high quality and a variety of surface functional groups, but also provide customized services of various types of microspheres, large-scale microsphere conjugation services with antibodies or nucleic acid probes, OEM services for microspheres and intermediates, and complete solutions for microsphere applications.

VectorBuilder

VectorBuilder is a revolutionary platform for all your custom vector designing, cloning, BAC modification, shRNA/CRISPR library and virus packaging needs. Our massive collection of vector backbones, promoters and ORFs ensures that we generate your vectors at a fraction of the cost and time that you would spend doing it yourself. Our online platform provides a highly intuitive work flow for you to design your desired vectors with just a few mouse clicks and then purchase the custom cloning of your designed vector. To date, we have delivered over 160,000 vectors and viruses. VectorBuilder truly is the next step in the evolution of cloning.

VGXI, Inc.

VGXI, Inc. is a leading contract manufacturer of DNA-based pharmaceuticals with 20 years of experience providing high quality cGMP products to clinical trials worldwide. Uses include DNA vaccines, immunotherapies, and cell and gene therapy applications. The company's continuous, low-shear AIRMIX® lysis technology and optimized purification process provide highly supercoiled plasmid with exceptional purity across all manufacturing scales. Production services include high quality plasmid for preclinical research, Highly Documented (HD) plasmid as a critical raw material for GMP viral vector production or pharm/tox studies, and cGMP plasmid DNA for clinical through commercial supply. Pre-Clinical through GMP RNA manufacturing services are also available.

ViroCell

Powering innovation on its journey from lab to life. 

ViroCell Biologics is a UK-based innovation-driven Contract Development and Manufacturing Organization (CDMO) that manufactures viral vectors and gene-modified cells to enable novel cell and gene therapies to enter clinical trials. 

 

VIVEbiotech

VIVEbiotech is a Contract Development and Manufacturing Organization -CDMO- developing and manufacturing lentiviral vectors under GMP standards with wide and robust experience in manufacturing vectors for rare/ultrarare diseases and for immune-cell therapy projects i.e. CAR-Ts, TCRs... 
 
VIVEbiotech is currently working on more than 35 projects according to both the FDA´s and the EMA´s regulations, and is manufacturing vectors for companies based in the US, Europe, Asia and Australia. 
 
VIVEbiotech has an R&D department as well as two process optimization departments for both upstream -USP- production and downstream -DSP- purification. The activities of these departments consist of improving the cost-effectiveness, scalability, regulatory or quality compliance of the production process, and the intrinsic biological characteristics of the vectors themselves.
 
VIVEbiotech very recently expanded facilities and has now seven cleanrooms fully and specifically set up for lentiviral-vector manufacturing. This has allowed significantly increasing our production capacity. 
 
In these facilities VIVEbiotech will be capable of manufacturing from early-stage to clinical- and commercial-scale batches.

Bronze

BioMarin Pharmaceuticals

With six products on the market and a fully-integrated multinational organization in place, BioMarin is providing innovative therapeutics to patients with serious unmet medical needs. The company is also currently conducting a clinical trial of an AAV-based potential gene therapy for hemophilia A.

ClearPoint Neuro

ClearPoint Neuro partners with pharmaceutical and biologics companies through all stages of therapy development, leveraging our FDA-cleared and CE marked solutions for direct CNS infusions.*  ClearPoint offers services, devices, and software to enable MRI-guided intraparenchymal and CSF delivery of gene, cell, and other therapies.  Our team has the expertise to guide you from the benchtop, into pre-clinical studies, through clinical trials, and onto post-commercialization with translational continuity.  We aim to provide an industry-leading cadence of innovation and caliber of services – all fully customizable to meet your program’s needs.

* Visit the ClearPoint Neuro website for more information on the SmartFlow Cannula’s regulatory clearance.

Intellia Therapeutics

Intellia Therapeutics, a leading clinical-stage genome editing company, is developing novel, potentially curative therapeutics leveraging CRISPR-based technologies. To fully realize the transformative potential of CRISPR-based technologies, Intellia is pursuing two primary approaches. The company’s in vivo programs use intravenously administered CRISPR as the therapy, in which proprietary delivery technology enables highly precise editing of disease-causing genes directly within specific target tissues. Intellia’s ex vivo programs use CRISPR to create the therapy by using engineered human cells to treat cancer and autoimmune diseases. Intellia’s deep scientific, technical and clinical development experience, along with its robust intellectual property portfolio, have enabled the company to take a leadership role in harnessing the full potential of genome editing to create new classes of genetic medicine.

Malvern Panalytical

Malvern Panalytical is a world leader in analytical characterization, creating expert solutions for the challenges associated with maximizing productivity, developing better quality products and getting them to market faster. We provide superior, customer-focused technologies, solutions and services which deliver tangible economic impact through chemical, biophysical and structural analysis. 

Rocket Pharmaceuticals, Inc.

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is advancing an integrated and sustainable pipeline of genetic therapies that correct the root cause of complex and rare childhood disorders. The Company’s platform-agnostic approach enables it to design the best therapy for each indication, creating potentially transformative options for patients afflicted with rare genetic diseases. Rocket's clinical programs using lentiviral vector (LVV)-based gene therapy are for the treatment of Fanconi Anemia (FA), a difficult to treat genetic disease that leads to bone marrow failure and potentially cancer, Leukocyte Adhesion Deficiency-I (LAD-I), a severe pediatric genetic disorder that causes recurrent and life-threatening infections which are frequently fatal, and Pyruvate Kinase Deficiency (PKD), a rare, monogenic red blood cell disorder resulting in increased red cell destruction and mild to life-threatening anemia. Rocket’s first clinical program using adeno-associated virus (AAV)-based gene therapy is for Danon Disease, a devastating, pediatric heart failure condition.

SparingVision

SparingVision is a genomic medicines company with a mission to translate pioneering science into vision saving treatments. Leveraging its unparalleled understanding of retinal diseases, SparingVision has built the world’s most compelling portfolio of synergistic cutting-edge gene therapy and genome editing treatments for inherited retinal diseases (IRDs). Both of its most advanced products, SPVN06 and SPVN20 look to go beyond single gene correction therapies to deliver new mutation agnostic treatments for Retinitis Pigmentosa (RP), a group of IRDs which are the leading cause of blindness globally. The Company also has a strategic collaboration with Intellia Therapeutics (NASDAQ:NTLA) to develop novel genome editing-based treatments for ocular diseases utilizing CRISPR-Cas9 technology.

SparingVision is backed by high-quality international investors including 4BIO Capital, AdBio Partners, Bpifrance, Foundation Fighting Blindness (US), Fondation Voir & Entendre, Intellia Therapeutics, UPMC Enterprises, Jeito Capital, Ysios Capital.

SwanBio Therapeutics

SwanBio Therapeutics aims to bring life-changing treatments to people with devastating, inherited neurological conditions. The company is advancing a pipeline of gene therapies designed to be delivered intrathecally to address targets within both the central and peripheral nervous systems. SwanBio’s lead program is the first clinical-stage AAV-based gene therapy for the treatment of adrenomyeloneuropathy (AMN).