Biocognate’s cell line development protocols leverage more than four decades of experience of its expert team involved in developing recombinant clones for regulated markets. The high productivity clones supplied by Biocognate using state-of-the-art platforms offer several advantages in manufacturing cost reduction and regulatory acceptance on scaling up.

Cell line development workflow is designed to reduce the time to obtain clones with established monoclonality and thus speed up the time to reach process development and subsequent process scale up. All the steps in the cell line development workflow are well documented and meets the stringent regulatory expectations at the time of BLA filing.

Biocognate offers off-the-shelf product cell lines for biosimilars along with optimized small-scale process and product characterization with respect to certain critical quality attributes. This enables dramatic fast-tracking of the pre-clinical and clinical development timelines for the partner organizations. Customized cell line development projects as per the requirements of the customer can also be taken up.