Our comprehensive package of Cell-Based cGMP Product Manufacturing services includes cGMP production of cells for clinical and commercial application from a variety of starting materials, including whole blood, apheresis, leukapheresis, bone marrow, tumor tissue, umbilical cord, adipose tissue, master & working cell banks, and single clone stocks among others. We’re able to swiftly scale-up and support production from clinical to commercial manufacturing. We offer a range of capacity options from shared and dedicated production suites up to custom configurations within larger dedicated capacity. We have also worked with clients on stand-alone dedicated capacity outside the US.
Our teams are skilled in a wide variety of technology platforms that can be used in the manufacturing process. We remain agnostic to the tools and technologies our clients use; instead, we are focused on providing our years of expertise and experience in best practices and scale-up to assist our clients in ways to improve safety and decrease costs of goods for the patient and industry.
Cognate offers preparation of cGMP master and working cell banks, fill-finish services, customized cryopreservation, manufacturing process validation from design to implementation, materials management, supply chain scheduling and integration. We manage the preparation of raw material specification, SOPs and batch production records, shipping and stability validation protocols, quality control testing, and the design and implementation of product release QC testing, characterization assays, and process performance qualifications (PPQs).
Additional capabilities include comprehensive QC assay transfer from GLP to cGMP and assay qualification and validation, as well as stability testing or validation for customized cell culture reagents and products, and bioburden, mycoplasma and endotoxin testing.
Cognate's manufacturing teams are supported by a full cGMP commercial manufacturing capabilities team. Our capabilities include integrated management systems, phase-appropriate quality management systems, in-process and release testing, technical operations, innovation team, assay development (AD), validation and qualification, and process development (PD) labs to support various phase appropriate requirements of your cell and gene therapy products.