Products & Services
Off-the-Shelf Biosimilars
Biocognate offers licensing of biosimilars of some of the blockbuster biological products. These biosimilar product packages would include high protein yielding recombinant clone with established monoclonality, R&D scale optimized process that is robust, reproducible and easily scalable. The package includes analytical data to demonstrate biosimilarity with respect to glycan, charge variants, primary sequence identity and ligand binding affinity.
Innovator product analytical data package
Various regulatory agencies emphasize on the biosimilarity data that at its core includes analytical data (both physico-chemical and functional) comparing the innovator product and intended biosimilar product. Having access to innovator analytical data range on some of the critical quality attributes (CQAs) is important for a biotech company to effectively develop process that would produce biosimilar molecule. Most companies put efforts in generating the innovator product quality data in-house, which is usually challenging. Biocognate would offer innovator product quality data package covering some of the CQAs, which would help the biosimilar developer to speed up their in-house product development timeline.
Modular biosimilars development services
Biocognate does offer customized biosimilar product development modular package. We can provide services to cover various phases of biosimilar development starting from cell line development to process development from 5L scale to pilot scale (50L). Customers can choose the stage of development that they would be interested in.