We want to be your partner and drive pioneering therapies to the market. We invest in enabling technologies and build expertise to support the development and commercialization of your new innovative therapy. Our scientists and engineers bring decade-long development experience across a broad spectrum of cell types and technologies. This builds the backbone of an extensive service offering, providing you with tailored process and analytical development, manufacturing and regulatory services.
Covance by Labcorp
Covance by Labcorp is a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 26,000 people worldwide, we provide comprehensive drug development solutions and are on a mission to advance health and power clear, confident decisions.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise.
Together with our clients, Covance by Labcorp supports the development of innovative, life-changing treatments.
BIA Separations has 20 years’ experience in chromatographic purification. Our products, CIM monoliths, were designed with unique operating properties that make them ideally suited to the challenging requirements of purifying biomolecules such as virus particles, vesicles, proteins, RNA’s, plasmids and other forms of DNA. We provide products that range from small analytical columns to large industrial prep-scale columns (including cGMP and disposable units) as well as method development services.
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.
Precision ADVANCE, the cell & gene therapy collective™
Precision Medicine Group has brought together targeted expertise that can propel drug development and access. We apply relevant insights and specialized capabilities to unlock the potential of data—accelerating drug development, advancing manufacturing, and elevating engagement to deliver commercial success.
Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focuses on the complexities of clinical, regulatory, manufacturing and commercial needs to successfully bring a cell or gene therapy to market.
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.
Patients First – it’s in our DNA. At CareMetx, we fight for every patient “from intake to outcomes” by providing Hub/reimbursement services, leading-class technology and strategic consulting to accelerate access to lifesaving treatments. Speed and efficiency – is why we’re different. CareMetx leverages our expertise and innovative patient eAccess technology to revolutionize the patient experience. We partner with our clients to launch or transition pharmaceutical programs in record time with significant cost savings.
Bio-Rad designs, manufactures, and distributes a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Founded in 1952, Bio-Rad has a global team of more than 7,750 employees and serves more than 100,000 research and industry customers worldwide through the company’s global network of operations.
MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany is skilled in the art of GMP viral vector production and technology innovation, having manufactured viral vectors for over 20 years and producing more than 500 lots of drug substance from preclinical through commercial production. Our comprehensive portfolio of best-in-class bioprocessing products and technologies combined with our application expertise can help you quickly scale up to reach your process goals.
PRA Health Sciences
PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.
With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.
At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.
Pall supports clients discovering, developing and producing pharmaceuticals, vaccines, cell and gene therapy products. Pall is the leading provider of bioprocessing, integrated automated systems and single-use solutions - from suspension and adherent cell bioreactors, through downstream purification, to formulation and filling. Process and product contract development services from cell culture through purification are offered, with extensive expertise in viral vector product development.
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.
The Jackson Laboratory
The Jackson Laboratory is the definitive resource for uncovering the genetic and molecular causes of genetic diseases. With ever-increasing precision, JAX® Mice, Clinical & Research Services provides the most innovative and unparalleled mouse models and research services, supporting the transition from discovery to application, resulting in individualized treatments and therapies.
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.
Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Previously GE Healthcare Life Sciences, Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman and Xcellerex. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients.
Mirus is a global leader and trusted brand in transfection for gene therapy research. Our TransIT-VirusGEN® Transfection Reagents provide superior titers for small-to-large scale production of AAV and lentiviral vectors, supporting gene therapy researchers from discovery to the clinic.
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.
Proteintech Group manufactures RUO and GMP-grade HumanKine recombinant proteins using a human expression system. Recombinant proteins created in HEK293 cells using animal-free components offers high bioactivity, stability and native human conformation and post-translational modifications. The RUO and GMP products are both manufactured using the same expression systems, production process and operating procedures in a GMP facility. This ensures that there is no variability in the quality and performance of these products, facilitating the smooth transition from pre-clinical to clinical.
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.
Volv is a data science company established in Switzerland with a global team and presence. Volv's methodology for finding patients with difficult to diagnose and rare diseases is called inTrigue.
inTrigue is a new way of building models using data science and machine learning to detect undiagnosed rare disease patients in population-scale databases such as electronic health records.
Volv’s mission is to speed science, reduce the cost of healthcare, and so enhance the economic output and well-being for all.
PPD® Biotech is devoted to finding the right Phase I-IV clinical development solutions for biotech and small to midsize pharma. With dedicated teams, PPD Biotech combines the global resource scalability and full-service offerings of PPD with personal attention, flexibility and a shared mindset that enables us to find the optimal solutions for your study, no matter the size.
Inspiring advances in bioprocessing, Repligen is a technology leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, Sweden, and Germany.
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.
Forge Biologics is a gene therapy manufacturing and development company helping clients achieve their cGMP program goals. Forge enables AAV vector production at 1-50L research and 50-500L cGMP grade scales, including process and analytical development. Our mission is to enable access to life changing gene therapies and help bring them from idea into reality.
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.
QPS is a global, science driven, customer-focused CRO that provides preclinical studies and clinical trials to the biotech and pharmaceutical industries. Our 1100+ person organization has expertise in nearly all drug modalities including small molecules, proteins, and other biotherapeutics. We have supported gene therapy since 2002: ASOs, siRNAs, miRNA through mRNAs and viral vectors. Our bioanalytical technologies include LC-HRMS, hybridization-LC, and qPCR; while our full spectrum DMPK services covers PK, DDI, biodistribution, and radiolabel studies.
Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing to position Catalent as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global network of clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. Catalent Cell & Gene Therapy has produced more than 100 cGMP batches across 70+ clinical and commercial programs.
An independent pharmacy and services provider, Anovo is dedicated to rare disease therapies and the people who rely upon them. Anovo provides specialty pharmacy, Hub, 3PL/Title model and distribution services all under one roof.
Therapy-dedicated teams offer reimbursement support, therapy education, and delivery services to enable quick, convenient and courteous access to therapy along with a positive therapy journey.
Our success is due to the time we invest in listening and collaborating with our manufacturer partners to develop custom programs that align with your goals and patient needs.
Delphi Genetics is a private biotech company with proven track record in genetic engineering and bioproduction. The company provides one-stop-shop service from development to GMP manufacturing of plasmid DNA for Cell & Gene Therapy applications, with a focus on DNA for viral vectors. Delphi Genetics has developed an innovative antibiotic-free technology (Staby®). Staby technology meets regulatory guidelines and drives a better plasmid DNA stabilization, and has been non-exclusively licensed to several big pharmaceutical companies.
Ology Bioservices (Ology Bio) is a biologics-focused Contract Development Manufacturing Organization (CDMO) serving both commercial and government clients from early-stage development through commercialization. Ology Bio provides services for up/downstream process development & optimization, analytical development & testing, CGMP manufacturing, and regulatory support for cell and gene therapies, live viral vaccines & vectors, monoclonal antibodies, oncolytic viruses, and recombinant proteins. To learn more about Ology Bio’s capabilities and services visit the company website at www.ologybio.com or contact the business development team at firstname.lastname@example.org
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.
PerkinElmer Genomics is a clinical molecular and biochemical laboratory offering an unmatched continuum of screening and diagnostic testing options, from newborn screening to whole genome sequencing. Our lab leverages PerkinElmer’s work-flow solutions to create unmatched efficiency and sustainability, enabling us to accelerate report delivery and increase affordability, empowering clinicians to utilize genetic testing earlier in the diagnostic process. Our team of experts takes pride in turning complexity into meaning.
Biocair is a global specialist courier with over 30 years of dedicated experience in the pharmaceutical, biotechnology and life science sectors. 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.
Diamond Pharma Services
Diamond are a leading European technical and regulatory affairs consultancy with extensive experience in the development of advanced therapies including supporting the development & marketing authorisation for both the first gene therapy (Glybera) and CAR-T (Yescarta) to be approved in Europe. Overall we have supported more than 40 gene, and gene modified cell therapy programmes. Our specialised team has broad and varied industry experience offering both breadth and depth of expertise, from which our clients can benefit. Diamond offers a comprehensive service including regulatory affairs, product development (nonclinical, CMC and clinical), pharmacovigilance and quality & compliance.
Mix Talent is a talent acquisition and consulting firm that specializes in pharmaceutical, biotech and gene therapy. We partner with companies to plan for, identify, assess, and recruit the talent they need to make their business successful.
At Mix, we believe culture is the key to securing top talent and top talent is the key to building and growing a truly magnetic culture. And we know this is especially important for companies focused on rare disorders where the patient population is small and the stakes are high.
We will help to bring your company’s mission and story to life, and then find the right candidates who will make your story stronger. Our experience, knowledge, and network with R&D, clinical, and commercial hires help our clients go beyond hiring just headcount to truly creating dynamic organizations.
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Working collaboratively with our clients, we specialize in providing innovative, tailored solutions supporting niche / orphan drug product launches, Just in Time labeling and packaging at ultra low temperatures and 3PL supply chains. These bespoke solutions enable life saving gene/cell therapy drug products to be delivered to patients when needed.
Our mission is to revolutionize scientific processes and data management in order to accelerate precision health across life sciences. Our end-to-end solutions and services yield efficiencies that enable researchers to make new genomics discoveries. The L7|ESP provides single data and process automation platform for all therapy-related information in a regulatory compliant way that supports better collaboration between all the stakeholders. L7|ESP links disparate systems with connectors to existing systems, apps to view the same data from one system, and interfaces with analytics tools. L7|ESP is easy to implement and user-driven and can overlay existing systems.
Beacon Targeted Therapies
Beacon Targeted Therapies, a competitive and research intelligence database solution designed in partnership with pharmaceutical professionals across the world working in targeted therapies to provide accurate, in-depth and real-time information in the rapidly evolving landscape of drug development.
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.