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. Learn more at Azzur.com.
Gene Therapy holds great promise for neurological diseases. Researchers are delivering these molecular treatments to the brain with precision and efficiency, in both small and larger animal species. This translation has armed scientists with potentially lifesaving treatments for humans. Working with a seasoned research partner like Charles River provides access to years of experience with every step of the process.
AllStripes is a healthcare technology company dedicated to unlocking new treatments for people affected by rare diseases. AllStripes’ technology platform generates regulatory-ready evidence to accelerate rare disease research and drug development, and empowers patients and families to securely participate in treatment research online and benefit from their own medical data — at no cost to participants. AllStripes was co-founded by CEO Nancy Yu and technology developer Onno Faber, following his diagnosis with the rare disease neurofibromatosis type 2. The company is backed by Lux Capital, JAZZ Venture Partners, Spark Capital, Medidata, McKesson Ventures, Maveron, and a number of angel investors.
Precision for Medicine
Precision for Medicine is the first full-service, global clinical research organization purpose-built to accelerate precision medicine research and development. Our expertise in rare and orphan diseases includes 150+ projects in 80+ diseases. Precision converges the power of clinical operations excellence, deep laboratory expertise, and advanced data sciences to maximize insight into patient biology, deliver more predictable trial outcomes and speed clinical development.
Our gene therapy expertise is mobilized through Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of the clinical, regulatory, manufacturing and commercial requirements to successfully bring a gene therapy to market. With over 2100 people and 35 offices worldwide, we stand ready to help accelerate your life-changing treatments anywhere around the globe.
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.
Thermo Fisher Scientific
Thermo Fisher Scientific provides industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to customers through our Patheon brand. Our Patheon Viral Vector Services business (formerly Brammer Bio) specializes in CDMO services for companies developing gene-modified cell therapies and in vivo gene therapies.Our key offerings include process and analytical development, clinical and commercial supply of viral vector drug substance and drug product, and regulatory support, enabling our clients to bring novel medicines to market.We are flexible to support every client’s unique product needs, timelines and regulatory pathways. Through recent investments in our world-class facilities and planned expansions, we are strategically positioned to support your immediate and long-term viral vector manufacturing needs.
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.
Mix Talent was built to support the near-term goals and long-term success of pharma, biotech, and gene therapy organizations. We leverage 30 years of experience in clinical and commercial executive search, sales builds, human resources, and talent assessment to anticipate your challenges and solve your complex problems, helping you grow your organization with full attention to your culture: the most powerful force for talent there is.
Optum Frontier Therapies
Creating access to therapies at the frontier of health care, Optum Frontier Therapies reimagines the specialty pharmacy experience by delivering one-stop distribution, tailored services, and data-backed clinical care and research. Our offerings ensure holistic impact for patients and their families, and support commercialization for manufacturing partners – from expertise in deep cold chain to wholesale distribution. As an independent business leveraging the best of Optum, our team is dedicated to building new models for advanced therapeutics.
Veristat is a CRO with a focus in accelerating clients’ rare disease therapies for unmet medical needs through the clinical development process. We've worked on more than 300 rare disease clinical projects and have prepared over 35 rare disease regulatory submissions. With experience in running trials for the first gene therapy approved in Europe, and over 20 gene therapy trials, Veristat is adept in providing comprehensive solutions for Advanced Therapies.
Halo Labs knows stability and particles. The Aura, our flagship product, can count and characterize subvisible particles - and tell you whether they are aggregated viral capsid, or external contaminants. A simple, plate-based approach enables low-volume (5µL), high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.
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.
Certara accelerates medicines to patients using biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. Our unique and regulatory-ready models for immunogenicity, immune-oncology, rare disease, vaccines and gene therapy are used by major pharmaceutical and emerging biotech companies.
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.
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Keeping pace with the rapidly evolving biotech environment requires the expertise to anticipate and adapt to development challenges before they happen. At Parexel Biotech, we work side-by-side with biotech companies to break down the development journey into a series of connected decisions, steps, and milestones - to get to that breakthrough innovation – from regulatory and commercial strategy to cutting-edge trial design and execution. We use our deep experience to bring you and your patients closer to better outcomes so you can get your innovation from the lab to the patients who need it most, faster. #NeverStopBioteching.
Polyplus-transfection applies its 20 years expertise to the development of novel transfection solutions, especially for viral vectors manufacturing for Gene & Cell Therapy. We are proud to provide the gold standard PEIpro, as well as the novel game changer FectoVIR-AAV, specifically designed for AAV production in suspension cells. Both reagents are available at RUO and GMP-grades, making them suitable from R&D to clinical trial and commercial scale, accompanied by a strong scientific and regulatory support.
Trinity Life Sciences
Trinity Life Sciences is a trusted strategic commercialization partner, providing evidence-based solutions for the life sciences. With over 25 years of experience, Trinity is committed to solving clients’ most challenging problems through exceptional levels of service, powerful tools and data-driven insights. Trinity’s range of products and solutions includes industry-leading benchmarking solutions, powered by TGaS Advisors. To learn more about how Trinity is elevating life sciences and driving evidence to action, visit trinitylifesciences.com.
Touchlight AAV is advancing gene therapy by offering its synthetic, linear, double stranded DNA as the new industry standard for transfection-based AAV production. We believe it is a safer, more effective, more scalable and faster way to manufacture AAV.
Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. For more than 35 years, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on Facebook, LinkedIn and Twitter.
With industry – leading experience, Cardinal Health bring unique understanding of the challenges of launching and commercializing cell and gene therapies – and how to effectively overcome them. Our proven solutions help manufacturers mitigate financial risk, navigate regulatory hurdles, manage end-to-end logistics and create access for patients.
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.
FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.
Deallus is a unique strategic intelligence consultancy operating across the global life sciences sector. Our mission is simple: to prepare you for the future by delivering the forward-thinking assurance you need in an uncertain and highly competitive world. The knowledge and clarity we provide helps life sciences companies shape future markets by making the right strategic decisions with confidence.
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.
Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression — including our proprietary CHEF1® Expression System for efficient protein production with CHO cells.
Our company DNA drives us to provide innovative solutions for clients to reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.
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.
VGXI, Inc. is a leading plasmid DNA CDMO with nearly 20 years of experience providing exceptional quality products to clinical trials worldwide. 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 purity plasmid for preclinical research, Highly Documented (HD) plasmid for GMP viral vector production or pharm/tox studies, and cGMP plasmid DNA for clinical through commercial supply.
emotive is multi-award winning, global healthcare communications agency with offices across the EU and US. Our highly skilled, experienced team is already a trusted partner for many leading biopharma companies in ATMP and rare disorders in the pre, peri and post launch stages of the product lifecycle.
We use our strategic scientific, creative and technical expertise to engage with HCPs, those living with a disorder and other stakeholders in the care pathway to stimulate advocacy and uptake of novel and innovative products.
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.
ProPharma Group is the global, independent, single-source provider of regulatory and compliance consulting, clinical research services, pharmacovigilance, and medical information serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, ProPharma Group has more than 1900 colleagues worldwide providing a comprehensive portfolio of regulatory, clinical and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With the mission to improve the health and safety of patients, ProPharma Group is focused on delivering the highest quality of services throughout the full product lifecycle.
QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalysis and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities.
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 28 years of experience, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support.
Gyros Protein Technologies
Gyros Protein Technologies provides enabling peptide synthesis and bioanalytical solutions helping scientists increase biomolecule performance and productivity in pre-clinical/clinical development and bioprocess applications. The nanoliter-scale Gyrolab® immunoassay platforms and expanding portfolio of kits are used by scientists in leading pharmaceutical, biotech and CRO/CMO companies in the development and manufacturing of biotherapies including cell and gene therapies. Gyrolab immunoassays provide key workflow advantages of speed, automation, and low sample and reagent usage with a wide dynamic range in applications including PK/PD, immunogenicity, titer determination, and analysis of bioprocess-related impurities. Gyros Protein Technologies is a division of Mesa Laboratories.
GenoSafe provides analytical testing services for the evaluation of quality, safety and efficacy of Gene and Cell therapy candidates including :
- biodistribution, shedding and immunogenicity studies on preclinical samples ;
- QC testing, such as viral titration, safety (e.g. replication-competent viruses) and potency/efficacy testing ;
- clinical 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.