The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for analyzing glycosylation profiles of expressed biosimilar proteins in mammalian cell clones, facilitating clone selection based on critical quality attributes (CQAs).
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To describe the procedure for assessing productivity of biosimilar-expressing cell clones using small-scale cultures to support early clone ranking and upstream development.
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To define the procedure for evaluating the genetic and phenotypic stability of biosimilar-producing clones across extended cell passages under laboratory conditions.
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To outline the procedure for the preparation, qualification, documentation, and storage of Master Cell Banks (MCBs) derived from biosimilar-producing cell lines intended for GMP manufacturing.
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