Tag: SOP for viral clearance in biosimilar production

Biosimilars: SOP for Deviation Handling During Clone Development – V 2.0

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Biosimilars: SOP for Deviation Handling During Clone Development – V 2.0 Standard Operating Procedure for Deviation Handling During Clone Development in Biosimilars Department Biosimilars SOP No. SOP/BS/050/2025 Supersedes SOP/BS/050/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline a systematic process for identifying, documenting, investigating,…

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Biosimilars: SOP for Documentation of Clone Selection and Results – V 2.0

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Biosimilars: SOP for Documentation of Clone Selection and Results – V 2.0 Standard Operating Procedure for Documentation of Clone Selection and Results in Biosimilar Development Department Biosimilars SOP No. SOP/BS/049/2025 Supersedes SOP/BS/049/2022 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 standardized system for…

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Biosimilars: SOP for Disposal of Biohazardous Cell Culture Waste – V 2.0

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Biosimilars: SOP for Disposal of Biohazardous Cell Culture Waste – V 2.0 Standard Operating Procedure for Disposal of Biohazardous Cell Culture Waste in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/048/2025 Supersedes SOP/BS/048/2022 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 standardized procedure for…

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Biosimilars: SOP for Cleaning and Decontamination of Cell Culture Areas – V 2.0

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Biosimilars: SOP for Cleaning and Decontamination of Cell Culture Areas – V 2.0 Standard Operating Procedure for Cleaning and Decontamination of Cell Culture Areas in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/047/2025 Supersedes SOP/BS/047/2022 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…

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Biosimilars: SOP for Use and Maintenance of Biosafety Cabinets – V 2.0

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Biosimilars: SOP for Use and Maintenance of Biosafety Cabinets – V 2.0 Standard Operating Procedure for Use and Maintenance of Biosafety Cabinets in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/046/2025 Supersedes SOP/BS/046/2022 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 standardized procedures for the…

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Biosimilars: SOP for Monitoring CO₂ Levels in Incubators – V 2.0

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Biosimilars: SOP for Monitoring CO₂ Levels in Incubators – V 2.0 Standard Operating Procedure for Monitoring CO₂ Levels in Incubators in Biosimilar Labs Department Biosimilars SOP No. SOP/BS/045/2025 Supersedes SOP/BS/045/2022 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 routine procedure for monitoring and…

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Biosimilars: SOP for Calibration of Incubators for Cell Growth – V 2.0

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Biosimilars: SOP for Calibration of Incubators for Cell Growth – V 2.0 Standard Operating Procedure for Calibration of Incubators for Cell Growth in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/044/2025 Supersedes SOP/BS/044/2022 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 the…

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Biosimilars: SOP for Microbial Contamination Monitoring – V 2.0

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Biosimilars: SOP for Microbial Contamination Monitoring – V 2.0 Standard Operating Procedure for Microbial Contamination Monitoring in Biosimilar Laboratories Department Biosimilars SOP No. SOP/BS/043/2025 Supersedes SOP/BS/043/2022 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 routine monitoring and control of microbial contamination…

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Biosimilars: SOP for Clone Archival and Inventory Management – V 2.0

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Biosimilars: SOP for Clone Archival and Inventory Management – V 2.0 Standard Operating Procedure for Clone Archival and Inventory Management in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/042/2025 Supersedes SOP/BS/042/2022 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 uniform and traceable procedure for…

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Biosimilars: SOP for Genetic Stability Testing – V 2.0

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Biosimilars: SOP for Genetic Stability Testing – V 2.0 Standard Operating Procedure for Genetic Stability Testing in Biosimilar Cell Lines Department Biosimilars SOP No. SOP/BS/041/2025 Supersedes SOP/BS/041/2022 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 standard procedure for assessing the genetic stability of…

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Biosimilars V 2.0