Development of robust manufacturing processes for late stage protein biopharmaceuticals must balance a number of factors including high productivity and purity, ease of manufacture, and product comparability to earlier internal material generated for clinical development.  For biosimilars, this balance is shifted heavily towards comparability as the target product profile is pre-defined by the originator product.  The expedited clinical development timelines for a biosimilar product imply that process development and characterization must be carried out following, likely, a single-cycle development model.  Under such aggressive development timelines, a developer of a biosimilar product must first determine the innovator’s product attribute profile.  The initial challenge falls to cell line development where those attributes inherent in the innovator cell line (e.g., carbohydrate) must closely match the ones of the selected cell line.  Upstream development is focused on productivity and minimizing unwanted product-related species. Downstream development is strongly challenged to tightly control product variants without sacrificing significant yield.  A case study will be presented with focus on the combined effort of four technical development groups (cell line technology, cell culture, purification and analytical) showcasing the challenges associated with the development of a biosimilar product.<br/>

Development of a biosimilar: Pooling efforts from all technical forces

251st National Meeting (2016)

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