Tag: chromatography SOP biosimilars

Biosimilars: SOP for Phase-Gate Review of Cell Line Progression – V 2.0 Standard Operating Procedure for Phase-Gate Review of Cell Line Progression in Biosimilar Development Department Biosimilars SOP No. SOP/BS/060/2025 Supersedes SOP/BS/060/2022 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 structured framework for…

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Biosimilars: SOP for Establishing Clone Performance Metrics – V 2.0 Standard Operating Procedure for Establishing Clone Performance Metrics in Biosimilar Cell Line Development Department Biosimilars SOP No. SOP/BS/059/2025 Supersedes SOP/BS/059/2022 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 methodology for defining, measuring, analyzing,…

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Biosimilars: SOP for Review and Approval of CLD Protocols – V 2.0 Standard Operating Procedure for Review and Approval of CLD Protocols in Biosimilars Department Biosimilars SOP No. SOP/BS/058/2025 Supersedes SOP/BS/058/2022 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 procedure for the…

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Biosimilars: SOP for Training Personnel in CLD Procedures – V 2.0 Standard Operating Procedure for Training Personnel in Cell Line Development Procedures Department Biosimilars SOP No. SOP/BS/057/2025 Supersedes SOP/BS/057/2022 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 training process for all personnel…

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Biosimilars: SOP for Data Integrity in CLD Operations – V 2.0 Standard Operating Procedure for Data Integrity in Cell Line Development Operations Department Biosimilars SOP No. SOP/BS/056/2025 Supersedes SOP/BS/056/2022 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 a systematic approach for preserving data integrity…

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Biosimilars: SOP for Troubleshooting Transfection Failures – V 2.0 Standard Operating Procedure for Troubleshooting Transfection Failures in Biosimilar Cell Line Development Department Biosimilars SOP No. SOP/BS/055/2025 Supersedes SOP/BS/055/2022 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 systematic approach for identifying and resolving transfection…

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Biosimilars: SOP for Audit Readiness of CLD Documentation – V 2.0 Standard Operating Procedure for Audit Readiness of CLD Documentation in Biosimilars Department Biosimilars SOP No. SOP/BS/054/2025 Supersedes SOP/BS/054/2022 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 maintaining the audit…

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Biosimilars: SOP for Transport of Cell Banks – V 2.0 Standard Operating Procedure for Transport of Cell Banks in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/053/2025 Supersedes SOP/BS/053/2022 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 validated, secure, and compliant method for the…

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Biosimilars: SOP for Harmonizing MCB/WCB Data with QA System – V 2.0 Standard Operating Procedure for Harmonizing MCB/WCB Data with QA System in Biosimilar Development Department Biosimilars SOP No. SOP/BS/052/2025 Supersedes SOP/BS/052/2022 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 harmonizing…

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Biosimilars: SOP for Periodic Review of Expression Cell Lines – V 2.0 Standard Operating Procedure for Periodic Review of Expression Cell Lines in Biosimilars Department Biosimilars SOP No. SOP/BS/051/2025 Supersedes SOP/BS/051/2022 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 standardized approach for the…

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