Analytical Challenges in Biosimilar Development

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researcher pipetting in biologics lab

Biosimilar Development

The development of a biosimilar requires the establishment of the quality target product profile (QTPP) early in the development cycle. To develop the QTPP, extensive analytical testing is required, including physiochemical and biological assays, to acquire a thorough understanding of the reference product. The challenge in performing such a task lies in determining the appropriate number of lots to evaluate and ensuring that the chosen lots are representative of the potential product variability and product degradation during storage. Another challenge is the establishment of release specifications, which need to be consistent with the reference product specifications. This paper will describe strategies on how to address these challenges.

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