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Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.
Many follow-on proteins in development are likely to be manufactured using novel expression systems. Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.
BioPharm: What are the common production and expression challenges for biosimilars?
Bulpin: The biggest challenge for biosimilar manufacturing is matching the protein quality attributes of the innovator molecule. Matching these attributes leads to a greater chance of success for similar innovator performance. There are different strategies to achieve this goal. One strategy is to screen multiple clones generated in different host cell lines. Alternatively, one can modify the protein quality attributes through media, feed, and process development.
BioPharm: What are the key considerations when selecting an expression system?
Bulpin: One of the main considerations when choosing an expression system is total cost of ownership. Attributes such as titer, stability, and time to market are all factors in total cost. In addition, intellectual property plays a role in the decision-making process. Clear intellectual property for ease of licensing and royalty-free licensing options are significant benefits when evaluating expression systems.
BioPharm: What advances have you seen in expression systems over the past five years? What improvements do these novel expression systems offer?
Bulpin: The commercial availability of off-the-shelf expression platforms has enabled customers to significantly reduce their cell line and process development timelines because these expression systems have optimized processes and products in place for streamlined development across multiple molecules. These improvements decrease timeline and personnel resources required to complete a cell line development project, which is crucial for speed to market.
Vol. 29, No. 12
When referring to this article, please cite as A. Siew, "Expression systems for the development of biosimilars," sidebar to “Large-Scale Protein Expression in Baculovirus-Infected Insect Cells," BioPharm International 29 (12) 2016.