Cognate’s cross functional teams deliver the expertise
necessary to engineer and overcome virtually any clinical
or commercial hurdle. We leverage years of manufacturing
and development experience in regenerative medicine and
blood-derived products for our clients.

Leverage our commercial scale cGMP production
capacity to effectively scale your autologous
or allogeneic cell and cell-mediated gene therapy
products from clinical trials into commercial production.

Cognate’s international manufacturing track record
for autologous and allogeneic cell therapies puts
Cognate in its own class of next generation CDMO’s.

Welcome to Cognate BioServices, Your CDMO Commercialization Partner.

Cognate BioServices is a leading contract development and manufacturing organization focused on cell and cell-mediated gene therapy products. We pride ourselves on the level of quality and experience we bring to the table. Cognate is unique in a number of ways--

  • Our late-stage expertise in personalized cell and gene therapies;
  • A wide range of operating, technical and leadership experience spanning cell and cell-mediated gene therapy products, with unique expertise in immunotherapy and regenerative medicine;
  • A commitment to commercial readiness and PAI inspection for personalized and off-the-shelf cellular immunotherapy products including but not limited to, CAR-T, TCR, TIL, MIL, DC, and NK cells.
In our operating history we’ve successfully manufactured and delivered products to and from the US, EU and Asia. We’ve handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics. We partner with our clients to provide regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells. Learn More

Clinical and Commercial Manufacturing

Cognate has unparalleled capabilities for autologous and allogeneic cell and cell-mediated gene therapy products such as CAR-T, TCR, TIL, MIL, DC, NK cell derived cell and cell-mediated gene-based immunotherapies as well as a broad spectrum of regenerative medicine products. Our international manufacturing expertise combined with a broad spectrum of targeted services for effective and optimized commercialization means the highest quality products will get to the patients who need them most -- when they need them.

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Process and Assay Development

Our vast experience providing full support for a range of regenerative medicine and blood-derived immunotherapy products throughout all stages of clinical and commercial development. Cognate provides the most efficient translation from concept to market and our experience can help our clients avoid unnecessary bottlenecks and navigate the unexpected.

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Logistics, Supply Chain and Support Services

Access a fully-integrated team of technical, quality assurance, quality control, manufacturing, process development, assay development and operational experts to put together the best plan for getting your product to the patients who need your products the most. Ancillary services are a combination of support, supply chain, logistics and other services that when combined and executed on properly ensure the highest quality product maintains traceability, consistency, and quality through all parts of the patient-to-patient process.

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Clinical, Regulatory and Custom Services

Outstanding real-world experience in navigating the evolving international regulatory pathways coupled with know-how in translating cGMP manufacturing between countries across the globe, and at the clinical site, where education of the investigators is critical to maintaining the level of quality and consistency required to execute clinical trials. Migrating from clinical to commercial, we understand how critical close integration with the clinical investigators is. Cognate is equipped with a commercial mindset and the experience to know how changes in technology and approach can impact our clients’ products. Whether it’s a new assay, new sampling plan, new storage procedure or process, or a new device that needs to be modified to scale, or a new element of creating a closed manufacturing process that’s required, Cognate can help.

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