Tag: SOP for working cell bank

Biosimilars: SOP for Regulatory Compliance for GMOs – V 2.0 Standard Operating Procedure for Regulatory Compliance for GMOs in Biosimilar Development Department Biosimilars SOP No. SOP/BS/040/2025 Supersedes SOP/BS/040/2022 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 complying with national and international…

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Biosimilars: SOP for Risk Assessment in Genetic Engineering – V 2.0 Standard Operating Procedure for Risk Assessment in Genetic Engineering for Biosimilar Development Department Biosimilars SOP No. SOP/BS/039/2025 Supersedes SOP/BS/039/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a systematic procedure for risk assessment…

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Biosimilars: SOP for Record Keeping for Cell Line Development – V 2.0 Standard Operating Procedure for Record Keeping for Cell Line Development in Biosimilars Department Biosimilars SOP No. SOP/BS/038/2025 Supersedes SOP/BS/038/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for record…

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Biosimilars: SOP for Handling Genetically Modified Organisms (GMO) – V 2.0 Standard Operating Procedure for Handling Genetically Modified Organisms (GMO) in Biosimilar Facilities Department Biosimilars SOP No. SOP/BS/037/2025 Supersedes SOP/BS/037/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for the safe handling,…

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Biosimilars: SOP for Biosafety Assessment of Cell Lines – V 2.0 Standard Operating Procedure for Biosafety Assessment of Cell Lines in Biosimilars Department Biosimilars SOP No. SOP/BS/036/2025 Supersedes SOP/BS/036/2022 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 procedures for conducting comprehensive biosafety assessment…

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Biosimilars: SOP for Stability Study of Engineered Clones – V 2.0 Standard Operating Procedure for Stability Study of Engineered Clones in Biosimilars Department Biosimilars SOP No. SOP/BS/035/2025 Supersedes SOP/BS/035/2022 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 conducting stability studies on…

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Biosimilars: SOP for Small-Scale Expression Screening – V 2.0 Standard Operating Procedure for Small-Scale Expression Screening in Biosimilars Department Biosimilars SOP No. SOP/BS/034/2025 Supersedes SOP/BS/034/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for evaluating the expression of biosimilar-producing clones in small-scale…

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Biosimilars: SOP for Cell Culture Media Optimization – V 2.0 Standard Operating Procedure for Cell Culture Media Optimization in Biosimilars Department Biosimilars SOP No. SOP/BS/033/2025 Supersedes SOP/BS/033/2022 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 optimizing cell culture media used for…

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Biosimilars: SOP for Viral Clearance in Cell Lines – V 2.0 Standard Operating Procedure for Viral Clearance in Biosimilar Cell Lines Department Biosimilars SOP No. SOP/BS/032/2025 Supersedes SOP/BS/032/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for evaluating and validating viral clearance…

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Biosimilars: SOP for Endotoxin Testing in Cell Culture – V 2.0 Standard Operating Procedure for Endotoxin Testing in Cell Culture for Biosimilars Department Biosimilars SOP No. SOP/BS/031/2025 Supersedes SOP/BS/031/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define a validated procedure for testing endotoxin levels…

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