Tag: protein purification SOP

Biosimilars: SOP for Cross-Department Communication During Upstream Events – V 2.0 Standard Operating Procedure for Cross-Department Communication During Upstream Events in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/150/2025 Supersedes SOP/BS/150/2022 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 structured communication framework for timely…

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Biosimilars: SOP for Alarms and Alerts Handling During Culture – V 2.0 Standard Operating Procedure for Alarms and Alerts Handling During Culture in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/149/2025 Supersedes SOP/BS/149/2022 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…

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Biosimilars: SOP for Contaminant Identification and Root Cause Analysis – V 2.0 Standard Operating Procedure for Contaminant Identification and Root Cause Analysis in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/148/2025 Supersedes SOP/BS/148/2022 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 structured approach for…

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Biosimilars: SOP for Culture Age Verification Prior to Inoculation – V 2.0 Standard Operating Procedure for Culture Age Verification Prior to Inoculation in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/147/2025 Supersedes SOP/BS/147/2022 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 verifying…

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Biosimilars: SOP for Use of Raw Materials in GMP Batches – V 2.0 Standard Operating Procedure for Use of Raw Materials in GMP Batches in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/146/2025 Supersedes SOP/BS/146/2022 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…

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Biosimilars: SOP for Evaluation of New Media Vendors – V 2.0 Standard Operating Procedure for Evaluation of New Media Vendors in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/145/2025 Supersedes SOP/BS/145/2022 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 evaluating and qualifying…

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Biosimilars: SOP for Cell Retention System Use (ATF, TFF) – V 2.0 Standard Operating Procedure for Cell Retention System Use (ATF, TFF) in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/144/2025 Supersedes SOP/BS/144/2022 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…

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Biosimilars: SOP for Continuous Culture Protocol – V 2.0 Standard Operating Procedure for Continuous Culture Protocol in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/143/2025 Supersedes SOP/BS/143/2022 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 protocol for establishing and managing continuous culture (chemostat or…

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Biosimilars: SOP for Reporting Critical Deviations to QA – V 2.0 Standard Operating Procedure for Reporting Critical Deviations to QA in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/142/2025 Supersedes SOP/BS/142/2022 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 promptly identifying, recording,…

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Biosimilars: SOP for Oxygen Mass Transfer Rate Determination – V 2.0 Standard Operating Procedure for Oxygen Mass Transfer Rate Determination in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/141/2025 Supersedes SOP/BS/141/2022 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 procedure for determining the…

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