Herceptin Biosimilar
Herceptin Biosimilar
Herceptin (trastuzumab) is a monoclonal antibody that targets the HER2 receptor and is a cornerstone therapy for HER2 positive breast and gastric cancers, improving survival when combined with chemotherapy.
Biocognate has developed several single cell clones expressing high levels trastuzumab biosimilar product. These clones have documented monoclonality evidence and are expressing > 5g/L protein in a shake-flask fed-batch process without any cell culture process development.
Protein titer results from a fed-batch study on day 14 conducted in shake flask (without cell culture process development) is shown in the table below for the top 5 single cell clones.
Assessment of charge variant and glycan profiles of trastuzumab from these clones indicate that there is either minimal or no process development needed to achieve biosimilarity. This can help in retaining the high protein titer of the clones and substantially improve the overall yield of the product during manufacturing.
These clones expressing high levels of trastuzumab are available for R&D and commercial in-licensing. Biocognate can also develop upstream and downstream process for any of these clones as per the requirement of the client. Interested clients can reach out to Biocognate team for further details.
