Leading Capabilities of Biosimilar Cell Line

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wendy wilson
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Leading Capabilities of Biosimilar Cell Line

The development process of biosimilars involves: 1) selection of a reference product that is off patent (hormone/cytokine/antibody); 2) in-depth analysis of the reference product to obtain the critical quality attributes (CQAs); 3) development of a manufacturing process to match the CQAs of the reference product involving cell line establishment and optimization, protein purification, rigorous similarity evaluations between the reference product and the biosimilar etc.