Tag: host cell protein removal SOP

Biosimilars: SOP for Inline UV Absorbance Monitoring – V 2.0

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Biosimilars: SOP for Inline UV Absorbance Monitoring – V 2.0 Standard Operating Procedure for Inline UV Absorbance Monitoring in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/200/2025 Supersedes SOP/BS/200/2022 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 a GMP-compliant procedure for operating, calibrating, and maintaining…

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Biosimilars: SOP for Resin Performance Qualification – V 2.0

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Biosimilars: SOP for Resin Performance Qualification – V 2.0 Standard Operating Procedure for Resin Performance Qualification in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/199/2025 Supersedes SOP/BS/199/2022 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 validated and GMP-compliant procedure for qualifying the performance of…

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Biosimilars: SOP for Chromatography Skid Calibration – V 2.0

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Biosimilars: SOP for Chromatography Skid Calibration – V 2.0 Standard Operating Procedure for Chromatography Skid Calibration in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/198/2025 Supersedes SOP/BS/198/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for the calibration of chromatography skid systems…

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Biosimilars: SOP for Deviation Handling in DSP – V 2.0

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Biosimilars: SOP for Deviation Handling in DSP – V 2.0 Standard Operating Procedure for Deviation Handling in Downstream Processing (DSP) in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/197/2025 Supersedes SOP/BS/197/2022 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 a systematic and GMP-compliant approach for…

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Biosimilars: SOP for Environmental Monitoring During Purification – V 2.0

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Biosimilars: SOP for Environmental Monitoring During Purification – V 2.0 Standard Operating Procedure for Environmental Monitoring During Purification in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/196/2025 Supersedes SOP/BS/196/2022 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 comprehensive and GMP-compliant procedure for environmental monitoring…

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Biosimilars: SOP for Filter Sterilization of Final Bulk – V 2.0

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Biosimilars: SOP for Filter Sterilization of Final Bulk – V 2.0 Standard Operating Procedure for Filter Sterilization of Final Bulk in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/195/2025 Supersedes SOP/BS/195/2022 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 GMP-compliant procedure for filter sterilization…

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Biosimilars: SOP for Product Contact Surface Management – V 2.0

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Biosimilars: SOP for Product Contact Surface Management – V 2.0 Standard Operating Procedure for Product Contact Surface Management in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/194/2025 Supersedes SOP/BS/194/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a GMP-compliant procedure for the management, cleaning, inspection,…

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Biosimilars: SOP for Hold Vessel Cleaning and Sterilization – V 2.0

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Biosimilars: SOP for Hold Vessel Cleaning and Sterilization – V 2.0 Standard Operating Procedure for Hold Vessel Cleaning and Sterilization in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/193/2025 Supersedes SOP/BS/193/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a GMP-compliant procedure for cleaning and…

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Biosimilars: SOP for Cold-Chain Handling and Transfer of Purified Bulk – V 2.0

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Biosimilars: SOP for Cold-Chain Handling and Transfer of Purified Bulk – V 2.0 Standard Operating Procedure for Cold-Chain Handling and Transfer of Purified Bulk in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/192/2025 Supersedes SOP/BS/192/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a validated,…

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Biosimilars: SOP for Storage of Purified Bulk Product – V 2.0

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Biosimilars: SOP for Storage of Purified Bulk Product – V 2.0 Standard Operating Procedure for Storage of Purified Bulk Product in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/191/2025 Supersedes SOP/BS/191/2022 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 a GMP-compliant procedure for the proper…

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Biosimilars V 2.0