Biocognate has the expertise to develop robust, reproducible, and seamlessly scalable processes that can allow the customers to reach process scale-up for clinical development quickly. There is a combined experience of more than three decades of process development at Biocognate.

Process development would involve use of chemically defined media and feeds with no animal origin products to provide highly consistent results and complete regulatory compliance.

Development of upstream cell culture process would be aimed at improving the productivity of the clones as well as reaching biosimilarity by assessing product quality eg. glycosylation and charge variants. Typical process development would be carried out at standard 5 L scale that can be easily scaled up as needed.

Downstream process development would provide the process scheme which would include the choice of resins for the chromatographic steps as well as the membranes for ultrafiltration as needed. It would include the different buffers to be used in the chromatographic processes along with a readout on the yield and quality from the individual chromatographic operations.

All the off-the-shelf products would come with the preliminary upstream process package along with the analytical data. Downstream process optimization is provided as an option.