Cognate BioServices is the leading contract development and manufacturing organization for the commercialization of complex living therapeutics. Cognate's unparalleled experience in cell and gene therapies translates to patients getting their products on time. We pride ourselves on the level of quality, adaptability and experience we bring to the table for our clients and their patients.
Cognate is the premier, commercial-ready CDMO in the industry with vast experience in managing all of the logistics and commercial readiness activities that large late-phase clinical trials require. Cognate's operational excellence and attention to detail ensures that we manufacture the safest and highest quality products, whether for clinical or commercial applications. Keeping your patients in the forefront of our daily activities drives all of us to go the extra mile.
Cognate provides a unique combination of custom development and cGMP manufacturing services to companies across all types of autologous and allogeneic clinical and commercial cell and gene therapy applications. While we can support all clinical phases of product development and manufacturing, Cognate specializes in mid to late-phase trials with an emphasis on scale-up, and commercial manufacturing. Cognate's commercial capacity and PAI readiness activities set it apart from the competition in terms of ability to scale with your product and patient needs.
Cognate provides a unique combination of custom services to organizations across all points of clinical and commercial development and manufacturing. We can support all clinical phases ranging from early preclinical studies, to mid-phase trials and product scale-up, through later stage clinical trials, culminating in commercial manufacturing.
We offer a comprehensive package for cell-based cGMP product manufacturing services. Cognate’s experience going back to 2002 has enabled our team to repeatedly execute complex manufacturing and logistics of personalized cell therapies, allogeneic cell banks, and other gene-mediated cell products. We offer phase-appropriate services from development through to commercialization in GMP suites supporting materials for supply to the US and EU markets. We offer as little as one production suite all the way to a custom-configured dedicated capacity model for commercial products.
Our state of the art 80,000+ sq. ft. cGMP facility is strategically located in Memphis, TN USA —a worldwide air hub for FedEx — enabling Cognate to send and receive shipments from anywhere in North and South America and Europe within 24 hours, with multiple choices of carriers. Cognate routinely handles both fresh and frozen products of all types.
Located near Baltimore Washington International Airport is Cognate’s GLP laboratory facility containing our growing team of process and assay development experts. Additionally, we have a team focused on efficient technology transfer of the work performed in Baltimore into our GMP manufacturing units in Memphis. Our facility is geographically situated in Baltimore because of longstanding relationships with NIH, John’s Hopkins and University of Maryland Medical Center as well as various biotechnology companies in the Eastern corridor.
Our Cobra Biologics International Centre of Excellence for ATMP Production, based on Keele Science Park in the UK, is dedicated to providing contract development and manufacturing services for both DNA and Viral Vectors from pre-clinical to clinical and commercial supply. With the Keele site founded in 1992 as a gene therapy company, and with 20+ years’ experience as a CDMO, Cobra has a unique knowledge base as both manufacturer and service provider for the global life sciences market.