Tag: protein purification SOP

Biosimilars: SOP for Cell Line Authentication – V 2.0 Standard Operating Procedure for Cell Line Authentication in Biosimilars Department Biosimilars SOP No. SOP/BS/030/2025 Supersedes SOP/BS/030/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the validated procedure for cell line authentication used in biosimilar production…

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Biosimilars: SOP for Mycoplasma Testing – V 2.0 Standard Operating Procedure for Mycoplasma Testing in Biosimilar Cell Banks Department Biosimilars SOP No. SOP/BS/029/2025 Supersedes SOP/BS/029/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for performing validated mycoplasma testing of Master Cell Bank…

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Biosimilars: SOP for Sterility Testing of Cell Banks – V 2.0

Biosimilars: SOP for Thawing of Frozen Cell Stocks – V 2.0 Standard Operating Procedure for Thawing of Frozen Cell Stocks in Biosimilar Development Department Biosimilars SOP No. SOP/BS/027/2025 Supersedes SOP/BS/027/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for safe, sterile, and…

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Biosimilars: SOP for Cryopreservation of Cell Banks – V 2.0 Standard Operating Procedure for Cryopreservation of Cell Banks in Biosimilars Department Biosimilars SOP No. SOP/BS/026/2025 Supersedes SOP/BS/026/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the standardized procedure for cryopreservation of biosimilar-producing cell banks…

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Biosimilars: SOP for Creation of Working Cell Bank (WCB) – V 2.0 Standard Operating Procedure for Creation of Working Cell Bank (WCB) for Biosimilars Department Biosimilars SOP No. SOP/BS/025/2025 Supersedes SOP/BS/025/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for the generation,…

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Biosimilars: SOP for Creation of Master Cell Bank (MCB) – V 2.0 Standard Operating Procedure for Creation of Master Cell Bank (MCB) in Biosimilars Department Biosimilars SOP No. SOP/BS/024/2025 Supersedes SOP/BS/024/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the procedure for the preparation,…

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Biosimilars: SOP for Clone Stability Assessment – V 2.0 Standard Operating Procedure for Clone Stability Assessment in Biosimilar Cell Line Development Department Biosimilars SOP No. SOP/BS/023/2025 Supersedes SOP/BS/023/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for evaluating the genetic and phenotypic…

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Biosimilars: SOP for Productivity Testing in Small-Scale Cultures – V 2.0 Standard Operating Procedure for Productivity Testing in Small-Scale Biosimilar Cultures Department Biosimilars SOP No. SOP/BS/022/2025 Supersedes SOP/BS/022/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for assessing productivity of biosimilar-expressing cell…

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Biosimilars: SOP for Glycosylation Analysis in Clone Selection – V 2.0 Standard Operating Procedure for Glycosylation Analysis in Biosimilar Clone Selection Department Biosimilars SOP No. SOP/BS/021/2025 Supersedes SOP/BS/021/2022 Page No. Page 1 of 15 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for analyzing glycosylation profiles of expressed…

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