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.
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.
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
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.
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
Viralgen is gene therapy CDMO, specializing in AAV therapeutics production, created to help broaden the access to life-saving therapeutics and contribute to the advancement of health and human welfare around the world. Through our proprietary Pro10™ suspension manufacturing platform, we deliver industry-leading titers and quality for all AAV serotypes to our client partners, optimizing speed to market and cost-of-goods to accelerate clinical development and commercialization.
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.
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, biopharmaceutical, and cell & gene therapy industries. With 29 years of experience, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support.
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.
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.
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.