Levers For Streamlining And Optimizing The Biosimilar Process
New and more advanced production methods mean biosimilar developers can produce their own versions of commercial drugs with greater efficiency. Levers like cell line engineering and bioreactor controls make it easier to increase productivity. Biologics Consulting Group Principal Consultant Vince Narbut walked through some of the unit operations ripe for optimizing during Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval.
When changing key processes, it is important to aim for the mid-range of reference product attribute data to ensure consistent similarity, since developers are now less likely to have clinical efficacy study data to fall back on.
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