Tag: biosimilar process validation SOP

Biosimilars: SOP for Removal of Host Cell Proteins – V 2.0 Standard Operating Procedure for Removal of Host Cell Proteins in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/170/2025 Supersedes SOP/BS/170/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the procedure for effective removal of…

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Biosimilars: SOP for Resin Regeneration and Storage – V 2.0 Standard Operating Procedure for Resin Regeneration and Storage in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/169/2025 Supersedes SOP/BS/169/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for the regeneration and storage of…

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Biosimilars: SOP for CIP of Chromatography Skids – V 2.0 Standard Operating Procedure for Cleaning-In-Place (CIP) of Chromatography Skids in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/168/2025 Supersedes SOP/BS/168/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for validated cleaning-in-place (CIP) of…

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Biosimilars: SOP for Resin Life Cycle Management – V 2.0 Standard Operating Procedure for Resin Life Cycle Management in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/167/2025 Supersedes SOP/BS/167/2022 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 managing the complete life cycle…

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Biosimilars: SOP for Sanitization of Chromatography Columns – V 2.0 Standard Operating Procedure for Sanitization of Chromatography Columns in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/166/2025 Supersedes SOP/BS/166/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for sanitizing chromatography columns used in…

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Biosimilars: SOP for Column Packing and Unpacking – V 2.0 Standard Operating Procedure for Column Packing and Unpacking in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/165/2025 Supersedes SOP/BS/165/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for packing and unpacking chromatography columns…

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Biosimilars: SOP for Polishing Step Using Size Exclusion Chromatography – V 2.0 Standard Operating Procedure for Polishing Step Using Size Exclusion Chromatography in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/164/2025 Supersedes SOP/BS/164/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for performing…

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Biosimilars: SOP for Hydrophobic Interaction Chromatography – V 2.0 Standard Operating Procedure for Hydrophobic Interaction Chromatography in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/163/2025 Supersedes SOP/BS/163/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the standard procedure for performing Hydrophobic Interaction Chromatography (HIC) for…

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Biosimilars: SOP for Optimization of Salt Gradient in IEX – V 2.0 Standard Operating Procedure for Optimization of Salt Gradient in IEX during Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/162/2025 Supersedes SOP/BS/162/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standard procedure for…

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Biosimilars: SOP for Strong Anion Exchange Chromatography – V 2.0 Standard Operating Procedure for Strong Anion Exchange Chromatography in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/161/2025 Supersedes SOP/BS/161/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standard procedure for conducting strong anion exchange…

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