Precision ADVANCE, a collection of interconnected services and complementary teams across Precision for Medicine, Project Farma, and Precision Value & Health are uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market.
Since 2013, Precision ADVANCE has helped advanced therapy innovators with 50+ cell and gene therapy clinical studies, 40+ facility builds and capital expansions with $4B+ in investment and supporting 70%+ of approved cell and gene therapies on the market.
BIA Separations, a Sartorius company, develops and manufactures market-leading CIM® monolithic chromatographic columns for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are applied in cell and gene therapies. BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics; BIA also has a keen presence with novel drug candidates in the clinical pipeline. Expecting continued strong double-digit sales growth over the next few years, BIA earned sales revenue approx. 25 million Euros in 2020, contributing to Sartorius Bioprocess Solutions, part of the Sartorius Group.
Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.
Invitae is bringing comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. As one of the fastest growing genetic information companies, Invitae is advancing the broad potential of genetics. The company provides genetic information services for all stages of life – from preconception screening, to newborn diagnosis, to inherited disease screening, to proactive health management – and a unique, rapidly expanding network of patients, hospital systems, and advocacy partners that is moving genetics from onedimensional testing to complex information management.
Accredo is a full-service specialty pharmacy. Accredo’s Rare Therapeutic Resource Center is dedicated to the treatment of complex, rare and ultra-orphan conditions. Our comprehensive therapy management program engages condition-specific pharmacists, nurses, social workers, dieticians, reimbursement specialists and patient care managers who provide dedicated support services to patients, their families and healthcare professionals.
Learn more at accredo.com
We provide biomanufacturing strategy and execution to startup and established pharmaceutical companies, advanced therapy companies, academia, hospitals, government agencies, financial institutions, CROs/CMOs, not-for-profit organizations and medical device companies. Our services include turnkey capital projects, tech transfers and facility builds; owner's representation; project and program management; validation; quality, regulatory and compliance; engineering and automation; serialization / track and trace; reliability, compliance and asset management; and more. We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.
Center for Breakthrough Medicines (CBM)
Center for Breakthrough Medicines (CBM) is an innovative cell and gene therapy focused contract development and manufacturing organization located in the heart of “Cellicon Valley.” CBM’s integrated and comprehensive service offering provides a one-source solution to accelerate speed to market for advanced therapies. A client-driven approach coupled with a patient-centric culture delivers high quality and reliable process and analytical development, viral vector manufacturing, GMP testing, cell therapy bioprocessing, plasmid production, and cell banking services for a full product’s life cycle.
Viralgen is a CDMO created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics. We specialize in the production of rAAV viral vectors with our proprietary Pro10™ suspension manufacturing platform, enabling 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, optimizing the cost-of-goods and accelerating clinical development and commercialization of life-changing genetic medicines.
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry-leading cGMP Contract Development and Manufacturing Organization (CDMO) supporting the biopharmaceutical industry in the development and production of biologics, vaccines and cell and gene therapies.
Our focus is to combine technical leadership in process development and cGMP manufacturing supported by a strong team of over 4,000 employees and a reputation for excellent customer service. We are a trusted partner of many clients, from early stage biotechs to large pharma.
AGC Biologics is a global CDMO providing end-to-end pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and the available capacity you need to accelerate your race to GMP. From development, to clinical trials, to full-scale commercialization, we can help you reach your goals at any stage in the drug development and manufacturing process.
We specialize in the following modalities and substances, mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA) and genetically engineered cells. Our services range from Process Development, Analytical Development, cGMP Manufacturing, Quality Control and Quality Assurance and Process Validation.
We forge exceptionally strong partnerships with our clients and we never lose sight of our commitment to deliver reliable and compliant drug substance. Right. On Time.
Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.
As a global company, Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.
Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.
Cardinal Health Advanced Therapy Solutions brings a unique understanding of the challenges of launching and commercializing cell and gene therapies (CGTs) — and how to overcome them effectively. Our early involvement, starting with assisting biopharma in establishing the first CAR-T products in 2017, has enabled us to develop tailored solutions to simplify and streamline the complexities of CGTs. Our clinical and commercial capabilities across the product lifecycle, from regulatory consulting to cryopreservation and shipping, help biopharma companies manage more variables so they can focus on bringing their advanced therapy to patients.
Oxford Biomedica Solutions
Oxford Biomedica Solutions is a leading cell and gene therapy solutions provider, offering fully integrated, end-to-end AAV services. We offer full scope process development and CGMP operations as well as a commercially ready platform and process. With our experienced and collaborative team of AAV experts, we have:
• Demonstrated >E15 vg/L titers
• Achieved >90% fully intact vector
• Analytical toolbox with over 45 methods
• Process scales from 2L to 2000L
• Six successful IND/CTA filings
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.
Partners4Access are global multi-award-winning access experts for orphan drugs, cell and gene therapy, partnering with the biotechnology industry to support new drug launches worldwide.
Our services focus on four key areas: evidence optimization, value communication, access performance and route to market, these are underpinned by our new launches of MAXConnect, our propriety in house payer network with over 250 handpicked payers, Patient and Caregiver Advisory Council (PCAC) and XINTA, our proprietary inhouse analogue database.
As one of the only consultancies with comprehensive experience in cell and gene therapies, P4A are excellently placed to help clients successfully achieve access.
Through various media initiatives, P4A are able to inform and shape the conversation around orphan drugs.
The team at P4A believe in striking an equilibrium in the rare disease world. That means helping drive access to the most appropriate treatments for patients and physicians, a fair return on investment for manufacturers at an affordable proposition for payers.
For more information, please visit P4A’s website: www.partners4access.com or email at firstname.lastname@example.org.
Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support 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.
InformedDNA® is the country’s leading applied genomics solutions company, helping people harness the full power of the genomics revolution. With the largest independent staff of board-certified genetics specialists in the U.S., InformedDNA ensures that health organizations have access to the highest quality, most current genomics insights to optimize clinical decisions.
Our solutions have helped optimize the health benefits of more than 100 million covered lives and have navigated hundreds of thousands of people to the right treatments or clinical studies/trials.
Key offerings for biopharma companies meet the challenges of patient recruitment screening and genetic data validation in precision medicine clinical trials. Our solutions extend beyond successful clinical trial execution to maximize post-market success in targeted populations.
InVitria was established in 2008 with the aim of developing, producing, and commercializing recombinant proteins for biomanufacturing and final formulation. The company utilizes a proprietary, plant-based technology called ExpressTec, which is based on the expression of recombinant proteins in rice, to produce its products. The ExpressTec platform is sustainable, scalable, and recombinant, making it suitable for a wide range of research, development, and clinical applications.
InVitria has over 1,000 active customers who use its products in the development of vaccines, gene therapies, cell therapies, regenerative medicine, and medical devices. The company's products are incorporated in 30 market-available products, including 11 therapeutics, and are sold in more than 40 countries and have received approvals from regulatory bodies such as the FDA, EMA, and PMDA.
InVitria's mission is to provide innovative products that help eliminate the use of animal-derived components, such as fetal bovine serum (FBS), human serum, and serum-derived proteins, in cell-based gene therapy procedures. This not only enhances the consistency, safety, and efficiency of gene therapy research and development but also reduces the risk of transmitting infectious agents, such as prions or viruses. The company's products are manufactured in compliance with Good Manufacturing Practices (GMP) and are designed to meet the needs of both research and clinical grade biomanufacturing applications.
In conclusion, InVitria is a leading innovator in the gene therapy field, committed to advancing the field through cutting-edge products, proprietary protein expression platforms, and innovative gene therapy manufacturing technologies. With its strong commitment to improving patient outcomes, InVitria is poised to make a significant impact in the coming years.
VGXI is a leading plasmid DNA manufacturer with over 20 years of experience providing high quality cGMP products to clients worldwide. Uses include DNA vaccines, immunotherapies, and cell & gene therapy applications. The company's continuous, low-shear AIRMIX® lysis technology and optimized purification process provide highly supercoiled plasmid with exceptional purity across manufacturing scales. Production services include high quality Pre-Clinical plasmid, Highly Documented (HD) plasmid as a raw material for GMP virus production, and cGMP plasmid DNA for clinical through commercial supply.
NorthX Biologics provides solutions for cell and gene therapy, vaccine, and therapeutic protein applications.
The company specializes in process development and manufacturing of plasmids, proteins, and other advanced biologics. The site is located in Matfors, Sweden and has been manufacturing biologics to GMP standards since 1988. In 2021 NorthX was recognized as a national innovation hub for advanced therapeutics and vaccines by the Swedish government and can support programs from pre-clinical through to commercial production. Check out www.nxbio.com for more information.
Avid Bioservices (NASDAQ:CDMO), an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 30 years of experience producing monoclonal antibodies and recombinant proteins, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
Forecyte Bio is a CDMO founded in 2021 to service the rapidly growing CGT industry. Built on decades of experience and expertise from its core technical team on CGT CMC processes, Forecyte Bio offers a 4x4TM holistic service package to accelerate clients’ projects, covering 4 technology platforms (Plasmid, Viral Vector, Cell Product, and RNA) at 4 developmental stages (R&D, Process and Assay Development, GMP, and regulatory filing). Our GMP capacities are available from both Frederick MD and Shanghai China sites. Our Viral Vector portfolio includes AAV, AdV, LVV, RV, and oncolytic viral vector.
Forecyte Bio is here to support and accelerate your CGT programs with Quality, Speed, and Agility.
As a recognized center of excellence in biopharmaceutical R&D and clinical manufacturing, Batavia Biosciences is driven to reduce human suffering from infectious disease and cancer. We accelerate the journey to the clinic by improving product yields, reducing process development time, and increasing product stability. We have expertise in viral vaccines, virotherapy, proteins and antibodies. We are not your standard CDMO – our customers regularly refer to us as their product development partner and thought partner.
Sampled is a next-generation laboratory that unlocks the valuable data in any biological sample. Through our integrated Sampled SMART Lab services, we can Store, Manage, Analyze, Research and Transport biological materials, offering partners a seamless solution for all research samples. Our vision is a world where we make it faster and easier for health innovators to improve human health, with a mission to be the Sampled SMART Lab behind every transformative health innovation.
Avance Biosciences is a leading CRO/CTL providing GLP & GMP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide. We have extensive experience working with many prominent Gene Therapy Rare Disease Therapeutic developers
Our customized cell and gene therapy assay solutions include: on/off target analysis of CRISPR edited genes by NGS assays; single cell % transduction assays for viral vector gene therapies; vector integration site analysis by NGS; preclinical PK & toxicity biodistribution studies; inserted vector and gene copy number analysis; replication competent lentivirus (RCL) assays, ID testing for AAV, lentivirus, sgRNA, mRNA, plasmids and other challenging test articles; and testing of DNA or mRNA in clinical trial human samples.
Cryoport Systems is the market leader in globally integrated temperature-controlled supply chain solutions for critical, irreplaceable products and materials in the life sciences industry. We are already trusted to support over 650 active clinical trials and 10 leading commercial products worldwide - delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. And, as the life sciences constantly evolve and advance, so do we.
TAAV Biomanufacturing Solutions
TAAV Biomanufacturing Solutions, S.L. (TAAV) is a cGMP manufacturer of doggybone DNA™ (dbDNA™), a synthetic DNA material used for adeno associated virus (AAV) gene therapies. The company is an independently operated, wholly owned subsidiary of Asklepios BioPharmaceuticals (AskBio) and, AskBio is an independent, wholly owned subsidiary of Bayer AG. dbDNA™ is manufactured using an enzymatic process and produced under ISO classified production suites following GMP standards for research, clinical and commercial applications of synthetic DNA in AAV therapeutic vectors. Synthetic dbDNA™ is an alternative to plasmid DNA, commonly used in AAV manufacturing, and leads to higher yields of DNA material. The use of synthetic dbDNA™ material can significantly shorten manufacturing timelines and facilitate faster production of AAV with an increased safety profile by eliminating residual bacterial sequences of plasmid DNA in the AAV product. TAAV was founded in 2019 and became 100% wholly owned by AskBio in 2022. Company headquarters, manufacturing facilities and labs are in San Sebastian, Spain.
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Andelyn Biosciences is a concept to commercialization CDMO that is dedicated to the mission of pioneering solutions to bring more treatments to more patients. A spinout of Nationwide Children’s Hospital, Andelyn has 20+ year history in cell and gene therapy development and GMP manufacturing, having produced over 450 sublots and supported over 75 INDs.
We have leveraged this knowledge to develop a robust suspension AAV manufacturing platform that has a linearity of scale from flask to 2000L as well as the flexibility needed to accommodate multiple serotype and transgene combinations.
Join us to see how we have achieved linearity in scale-up, consistency in production and learn our approach in making the development cycle a part of the platform to leverage accelerators and multipliers throughout the product lifecycle.
Shanghai Model Organisms
Founded in 2000, Shanghai Model Organisms Center, Inc. (SMOC) is a leading company in China to offer high-quality animal models and related services to global researchers.
SMOC strives to be the best-in-class resource center for biomedical researchers and industry partners, with its highly efficient and reliable technology platform. We have been dedicated to developing a comprehensive product portfolio, comprised of both highly customized solutions like GEM models and off-the-shelf products. Nowadays SMOC owns a rapidly expanding repository of Research-Ready models, many of which are designed for cutting-edge biomedical research like rare disease therapy, immuno-oncology studies and therapeutic antibody development. Additionally, our company provides a wide range of CRO services including in vivo PD evaluations, in vivo Pharmacological assays, pathological/Toxicological assays and in vitro Pharmacology.
The supply of animal models to our customers is assured by our state-of-art animal facilities. Currently SMOC operates multiple AAALAC accredited breeding facilities in Shanghai, and owns 100,000 specific-pathogen free (SPF) cages that are available for 500,000 mice. In the past decade, SMOC has established a global service network powered by our superior technical platform, talented scientific team and a group of dedicated technical support staff. We proudly work together with researchers from world-renowned academic institutes across the US, EU and APAC, as well as top pharmaceutical companies both domestically and internationally.
Please feel free to contact us if you are interested in or have any questions of our services.
Genevoyager focuses on AAV gene therapy technology innovation and collaborations to benefit patients by speeding up the manufacturing process while reducing costs for both R&D and manufacturing. We provide one-stop CDMO services using the baculovirus One-Bac 4.0TM platform with high yields, high stability, high full-capsid ratio, and high infective activity. For large-scale manufacturing, the yield of a single batch can reach 1E+18vg at reduced costs with a fast delivery time. BrainVTA, a Genevoyager company, provides 3,000+ pre-made viral vectors and CRO services for gene therapy.
Magnolia is a full-service research consultancy to some of the world’s most innovative healthcare companies. Since 2013, we have established strong thought partnerships with clients in rare diseases by delivering comprehensive, evidence-based insights, with actionable recommendations that lead to better commercial results.
Between crafting market and burden of disease strategies, HEOR planning and patient journey mapping, developing messaging that resonates with stakeholders, or finding KOLs and patients with ultra-rare diseases, Magnolia supports you from foundational strategy through post-launch.
Akron Bio drives advanced therapy development and commercialization with high-quality, industrial-scale solutions. Akron’s strategic focus is supplying cGMP-compliant ancillary materials and services to enable the advancement of cell and gene therapies. These include cytokines and growth factors, human sera and purified proteins, plasmid DNA manufacturing, and custom development services. As a regulatory-compliant company (ISO certified), Akron supports clients with rigorous documentation and quality standards to fulfill their regulatory demands. Our unique capabilities allow us to seamlessly transition from R&D to preclinical and clinical development with minimal change control and thus drive the emerging regenerative medicine sector to unmet clinical needs through affordable and seamless manufacturing options.
Comradis® and Seques® are specialist healthcare communications and consultancy agencies working exclusively on rare diseases, orphan drugs and cell and gene therapies. Our team includes rare disease consultants, gene therapy communications experts, clinical geneticists and experienced healthcare and patient advocacy professionals.
With experience working across more than 50 rare diseases and 15 cell and gene therapies, we are highly skilled in delivering clear and compelling healthcare communications in these complex and unique areas, including:
- Congresses and educational meetings
- Publication planning and delivery
- Scientific communications platforms and messaging development
- Patient engagement activities
- Omni- and multichannel strategies, digital tools and resources
- Advisory boards and insights gathering
- Internal training activities
- Medical and clinical trial educational resources
- Stakeholder mapping
- Strategic consultancy and planning
To secure a better future for families affected by rare diseases and cell and gene therapies, we develop partnerships with pharmaceutical and biotechnology clients, patients, caregivers, advocates and clinicians. We focus on people, not statistics. Our goal is to look beyond the data to provide meaningful content. To learn more about how we can help you communicate and commercialize treatments in these unique area, please get in touch.
Comradis® and Seques® are part of AMICULUM®, an independent family of 11 specialist healthcare communications agencies with over 350 medical communications professionals in 14 worldwide locations.
What makes us different is our agile and highly collaborative approach, which allows us to put together the right expertise from across our business to deliver high-quality, technically accurate and compelling content for different audiences, through selective use of key communication channels.
Triangle Insights Group
TRIANGLE INSIGHTS GROUP is a premier strategy consulting firm providing guidance on critical business issues to life science industry leaders. The firm’s approach combines deep industry knowledge with strong analytical rigor to drive strategic decision-making across client domains. Triangle’s expertise encompasses key therapeutic areas (Oncology, CNS, Cell and Gene Therapy) and relevant industry disciplines (Pricing and Market Access, New Product Planning, and Commercial Strategy).
INSIGHTS THAT INSTILL CONFIDENCE
We are a clinical trial and pipeline database solution designed in partnership with pharmaceutical professionals. We track targeted therapies to provide accurate, in-depth, and real-time information in the rapidly evolving drug development landscape. For more information or to request a demo, visit our website.