Overview

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies. We pride ourselves in the level of quality and experience we bring to the table. We are unique in a number of ways, including but not limited to:

  • Our late stage experience in personalized cellular therapies;
  • A wide range of operating, technical and leadership experience spanning cellular 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, and we’ve handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics, and regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells.

Cognate – Your CDMO Commercialization Partner

Cognate is a dynamic, results-driven, organization focused on providing the broadest range of commercialization services to regenerative medicine, cellular immunotherapy and advance cell therapy companies, organizations and institutions. Cognate provides a unique combination of custom services to companies across all points of clinical and commercial development ranging from early preclinical studies, to mid phase trials and product scale-up though later stage clinical trials and bridging into commercial manufacturing. Cognate applies the know-how and expertise of its business, scientific and technical teams to successfully develop autologous and allogeneic products across multiple cell-based technology platforms from start to finish.

Our leadership team has been on both sides of the negotiating table when it comes to developing drugs, and understands the critical importance of selecting a CDMO that can be a true partner and one that understands the process completely. As with any growing relationship, we understand the critical importance of communication, and we have established a unique operating cadence with our clients that is tailored to the client’s needs and capabilities. Cognate’s leadership, because of its operating experience on both sides of the table, also realizes the critical importance of being agnostic to technology, but at the same time, having the specific experience in a wide variety of instruments and techniques that can be leveraged to create the most effective solution for the product and client. To this end, we have created an approach with various technology developers to enable rapid PD and TT in Cognate’s Center of Excellence. This growing part of our organization selects the best of breed technology vendors and works with them to create a process that enables a highly confidential review of the current technology used by the client in comparison with the state of the art technology and/or process improvements that can enable scale up of the process, without creating unnecessary regulatory issues.

Cognate can hit the ground running at virtually any developmental stage, starting with a gap analysis tailored to the customer’s developmental stage. Whether the client needs planning, and/or analysis of academic clinical packages, a cost-effective solution for product development and clinical phase planning, product characterization studies, scale up and planning for commercial roll-out and pre-approval inspection or pre-licensing inspection or validation and testing of established processes, we can seamlessly and rapidly help you achieve your milestones. From a commercialization focus, we can rapidly integrate upstream work into your manufacturing process, and with our capacity and current clinical to commercial translation services, we believe we can accelerate our clients time to market. Our international manufacturing experience can be leveraged to help our clients navigate the demanding developmental requirements for cell-based and regenerative medicine products and technologies across the globe, translating to early achievable commercial and/or developmental milestones.

Our goal is to support our client’s scalable product development efforts in bringing their product as quickly and safely as possible to the patient, with the highest quality achievable.