Biogen Idec, the world’s oldest independent biotechnology company, and Samsung Bioepis, are jointly developing high-quality biosimilar medicinal products in several key therapeutic areas.  This innovative joint venture leverages Biogen Idec’s state-of-the art development capability, global manufacturing network and proven track record in commercializing complex biological drugs, to meet the growing global demand for highly efficacious and affordable therapies.  Unlike small molecule drugs, whose structure and formulations can be completely reproduced, biopharmaceutical products are complex proteins produced by living cells, whose structures and properties may not be fully replicated by a biosimilar product.  While the safety and efficacy of innovator products are well understood, the different cell lines and cell culture processes used to produce biosimilars may result in meaningful differences that may impact safety and efficacy.  The highest quality biosimilars will not have differences that are clinically relevant, and will be manufactured to the same high standards of quality as achieved by innovator companies.  To minimize clinically relevant differences between the biosimilar and the reference product, Biogen Idec completes a comprehensive <i>in vitro</i> analysis of the reference product and use a risk-based approach to define critical quality attributes (CQAs) and product quality ranges that need to be matched by the biosimilar product.  With biosimilarity criteria defined, a cell line that produces a product similar to the reference product is developed, and advanced mammalian cell culture techniques are used to further refine the biosimilar product profile.  After cell culture optimization, meaningful differences may remain between the biosimilar and the reference product that will need to be addressed by the purification process.  This presentation will focus on the unique purification challenges associated with the development of biosimilars, and innovative purification techniques that have been employed to modulate certain CQAs (including levels of product-related species, glycan species, and biological activity) to achieve a higher degree of biosimilarity.  Considerations for the design of control strategies to ensure robust large-scale manufacturing will also be discussed.

Overcoming challenges in biosimilar process development: Innovative purification tools to fine-tune biosimilarity

249th National Meeting (2015)

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