Tag: downstream processing SOP

Biosimilars: SOP for DSP Process Validation Sampling – V 2.0

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Biosimilars: SOP for DSP Process Validation Sampling – V 2.0 Standard Operating Procedure for DSP Process Validation Sampling in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/190/2025 Supersedes SOP/BS/190/2022 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 and GMP-compliant procedure for collecting, handling,…

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Biosimilars: SOP for Chromatogram Review and Analysis – V 2.0

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Biosimilars: SOP for Chromatogram Review and Analysis – V 2.0 Standard Operating Procedure for Chromatogram Review and Analysis in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/189/2025 Supersedes SOP/BS/189/2022 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 standard procedure for reviewing and analyzing chromatograms…

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Biosimilars: SOP for Precipitation and Clarification Steps – V 2.0

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Biosimilars: SOP for Precipitation and Clarification Steps – V 2.0 Standard Operating Procedure for Precipitation and Clarification Steps in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/188/2025 Supersedes SOP/BS/188/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe a GMP-compliant procedure for executing precipitation and clarification…

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Biosimilars: SOP for Endotoxin Removal in Bacterial Systems – V 2.0

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Biosimilars: SOP for Endotoxin Removal in Bacterial Systems – V 2.0 Standard Operating Procedure for Endotoxin Removal in Bacterial Systems in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/187/2025 Supersedes SOP/BS/187/2022 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 validated and GMP-compliant procedure for…

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Biosimilars: SOP for Inclusion Body Solubilization (if expressed in E. coli) – V 2.0

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Biosimilars: SOP for Inclusion Body Solubilization (if expressed in E. coli) – V 2.0 Standard Operating Procedure for Inclusion Body Solubilization (if expressed in E. coli) in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/186/2025 Supersedes SOP/BS/186/2022 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…

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Biosimilars: SOP for Reduction and Alkylation (if applicable) – V 2.0

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Biosimilars: SOP for Reduction and Alkylation (if applicable) – V 2.0 Standard Operating Procedure for Reduction and Alkylation (if applicable) in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/185/2025 Supersedes SOP/BS/185/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for performing controlled reduction…

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Biosimilars: SOP for Protein Refolding (if applicable) – V 2.0

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Biosimilars: SOP for Protein Refolding (if applicable) – V 2.0 Standard Operating Procedure for Protein Refolding (if applicable) in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/184/2025 Supersedes SOP/BS/184/2022 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 protein refolding of biosimilar…

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Biosimilars: SOP for Use of Single-Use Systems in DSP – V 2.0

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Biosimilars: SOP for Use of Single-Use Systems in DSP – V 2.0 Standard Operating Procedure for Use of Single-Use Systems in DSP in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/183/2025 Supersedes SOP/BS/183/2022 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 the…

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Biosimilars: SOP for pH Adjustment of Bulk Protein Solution – V 2.0

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Biosimilars: SOP for pH Adjustment of Bulk Protein Solution – V 2.0 Standard Operating Procedure for pH Adjustment of Bulk Protein Solution in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/182/2025 Supersedes SOP/BS/182/2022 Page No. Page 1 of 9 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To provide a controlled procedure for…

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Biosimilars: SOP for Concentration Adjustment Post-UF – V 2.0

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Biosimilars: SOP for Concentration Adjustment Post-UF – V 2.0 Standard Operating Procedure for Concentration Adjustment Post-UF in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/181/2025 Supersedes SOP/BS/181/2022 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 procedure for adjusting the protein concentration of biosimilar…

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Biosimilars V 2.0