Tag: SOP for bioreactor inoculation biosimilars

Biosimilars: SOP for Dissolved Oxygen (DO) Control in Bioreactor Operations – V 2.0

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Biosimilars: SOP for Dissolved Oxygen (DO) Control in Bioreactor Operations – V 2.0 Standard Operating Procedure for Dissolved Oxygen (DO) Control in Bioreactor Operations for Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/070/2025 Supersedes SOP/BS/070/2022 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…

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Biosimilars: SOP for pH Monitoring and Adjustment in Bioreactor Operations – V 2.0

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Biosimilars: SOP for pH Monitoring and Adjustment in Bioreactor Operations – V 2.0 Standard Operating Procedure for pH Monitoring and Adjustment in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/069/2025 Supersedes SOP/BS/069/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To provide a standardized procedure…

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Biosimilars: SOP for Temperature Control in Bioreactor Operations – V 2.0

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Biosimilars: SOP for Temperature Control in Bioreactor Operations – V 2.0 Standard Operating Procedure for Temperature Control in Bioreactor Operations for Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/068/2025 Supersedes SOP/BS/068/2022 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 controlling, monitoring, and…

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Biosimilars: SOP for Inoculation of Bioreactors – V 2.0

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Biosimilars: SOP for Inoculation of Bioreactors – V 2.0 Standard Operating Procedure for Inoculation of Bioreactors in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/067/2025 Supersedes SOP/BS/067/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for inoculating bioreactors under aseptic conditions with…

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Biosimilars: SOP for Scale-Up from Shake Flask to Spinner Flask – V 2.0

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Biosimilars: SOP for Scale-Up from Shake Flask to Spinner Flask – V 2.0 Standard Operating Procedure for Scale-Up from Shake Flask to Spinner Flask in Biosimilar Production Department Biosimilars SOP No. SOP/BS/066/2025 Supersedes SOP/BS/066/2022 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…

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Biosimilars: SOP for Inoculation of Shake Flasks – V 2.0

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Biosimilars: SOP for Inoculation of Shake Flasks – V 2.0 Standard Operating Procedure for Inoculation of Shake Flasks in Biosimilar Upstream Processing Department Biosimilars SOP No. SOP/BS/065/2025 Supersedes SOP/BS/065/2022 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 the procedure for aseptic inoculation of shake…

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Biosimilars: SOP for Setup and Sterilization of Bioreactor Vessels – V 2.0

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Biosimilars: SOP for Setup and Sterilization of Bioreactor Vessels – V 2.0 Standard Operating Procedure for Setup and Sterilization of Bioreactor Vessels in Biosimilar Production Department Biosimilars SOP No. SOP/BS/064/2025 Supersedes SOP/BS/064/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for…

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Biosimilars: SOP for Use of Chemically Defined Media – V 2.0

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Biosimilars: SOP for Use of Chemically Defined Media – V 2.0 Standard Operating Procedure for Use of Chemically Defined Media in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/063/2025 Supersedes SOP/BS/063/2022 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 standardized procedure for selection, preparation,…

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Biosimilars: SOP for Media Preparation and Sterilization – V 2.0

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Biosimilars: SOP for Media Preparation and Sterilization – V 2.0 Standard Operating Procedure for Media Preparation and Sterilization in Biosimilar Upstream Processing Department Biosimilars SOP No. SOP/BS/062/2025 Supersedes SOP/BS/062/2022 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 accurate preparation, sterilization, and…

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Biosimilars: SOP for Preparation of Seed Culture – V 2.0

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Biosimilars: SOP for Preparation of Seed Culture – V 2.0 Standard Operating Procedure for Preparation of Seed Culture in Biosimilar Production Department Biosimilars SOP No. SOP/BS/061/2025 Supersedes SOP/BS/061/2022 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 standard procedure for preparation of seed culture…

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