When you partner with Cognate, our teams become one with yours. We strive to function as a single body, our staff and yours, with a combined focus on the mission at hand – creating life-saving biotherapeutics for patients that need them the most. Our people become extensions of your organization and experts on your cell & gene therapy manufacturing needs. We understand that every client project, no matter its size, is critical—and we treat it that way.
Unlike other CDMOs, we are technology agnostic. Many other cell therapy CMOs require you to conform to their process or utilize their technologies. Not with Cognate! Whatever your needs or preferences may be, we will procure the needed devices, install, and train our staff on your specific program. Read more about our approach to technology transfer here!
Cognate understands that every product that leaves our facility has the potential to positively impact a patient’s life. Focused on quality, safety and compliance, we have a long-established record of exceptional service with a deep bench of experienced quality professionals. Cognate has been inspected by numerous regulatory bodies over the course of our nearly 20 years of operation, have met or exceeded requirements of both U.S. and E.U. regulators, and have never received an FDA Form 483. Our quality teams will work with your organization to prepare for any necessary audits and can assist in regulatory submissions for your process, product and required QC analytical methods. Read more about our Commitment to Quality here!
Because of PLI-ready activities for many clients, Cognate can help with a path for commercialization when you’re ready. We have experience with late-phase autologous and allogeneic products and have supported logistics to more than 22 countries. Additionally, Cognate provides all aspects of manufacturing, from DNA and viral vectors through cGMP cell therapy manufacturing and fill-finish. A collaborative mindset with our clients has helped us grow to over 500 commercially minded people.
Our cross-functional teams deliver the expertise necessary to engineer and overcome virtually any clinical or commercial hurdle. We understand that developing and manufacturing cell and gene-mediated therapy products is only a small part of the logistic challenges you face. That is why Cognate is equally focused on providing best in class development of processes, assays, clinical and CMC support, supply chain management, and phase-appropriate guidance to your organization through commercialization. Your success is our success.