Tag: SOP for glycosylation analysis in biosimilars

Biosimilars: SOP for Use of Single-Use Bioreactor Systems – V 2.0 Standard Operating Procedure for Use of Single-Use Bioreactor Systems in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/100/2025 Supersedes SOP/BS/100/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the standard procedure for the preparation,…

Read More “Biosimilars: SOP for Use of Single-Use Bioreactor Systems – V 2.0” »

Biosimilars: SOP for Media Hold Time Validation in Bioreactor Operations – V 2.0 Standard Operating Procedure for Media Hold Time Validation in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/099/2025 Supersedes SOP/BS/099/2022 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…

Read More “Biosimilars: SOP for Media Hold Time Validation in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Cleaning and Sanitization of Bioreactors – V 2.0 Standard Operating Procedure for Cleaning and Sanitization of Bioreactors in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/098/2025 Supersedes SOP/BS/098/2022 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 validated cleaning and sanitization procedures…

Read More “Biosimilars: SOP for Cleaning and Sanitization of Bioreactors – V 2.0” »

Biosimilars: SOP for Sterile Addition of Feeds and Supplements in Bioreactor Operations – V 2.0 Standard Operating Procedure for Sterile Addition of Feeds and Supplements in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/097/2025 Supersedes SOP/BS/097/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To…

Read More “Biosimilars: SOP for Sterile Addition of Feeds and Supplements in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Inline Analytics (Raman, NIR) in Bioreactor Operations – V 2.0 Standard Operating Procedure for Inline Analytics (Raman, NIR) in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/096/2025 Supersedes SOP/BS/096/2022 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…

Read More “Biosimilars: SOP for Inline Analytics (Raman, NIR) in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Calibration of pH and DO Sensors in Bioreactor Operations – V 2.0 Standard Operating Procedure for Calibration of pH and DO Sensors in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/095/2025 Supersedes SOP/BS/095/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To…

Read More “Biosimilars: SOP for Calibration of pH and DO Sensors in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Temperature Mapping of Bioreactor Jackets – V 2.0 Standard Operating Procedure for Temperature Mapping of Bioreactor Jackets in Biosimilar Operations Department Biosimilars SOP No. SOP/BS/094/2025 Supersedes SOP/BS/094/2022 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 method for temperature mapping…

Read More “Biosimilars: SOP for Temperature Mapping of Bioreactor Jackets – V 2.0” »

Biosimilars: SOP for Pressure Vessel Safety Checks in Bioreactor Operations – V 2.0 Standard Operating Procedure for Pressure Vessel Safety Checks in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/093/2025 Supersedes SOP/BS/093/2022 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…

Read More “Biosimilars: SOP for Pressure Vessel Safety Checks in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Cross-Contamination Control in Bioreactor Operations – V 2.0 Standard Operating Procedure for Cross-Contamination Control in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/092/2025 Supersedes SOP/BS/092/2022 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 systematic measures for controlling cross-contamination in bioreactor…

Read More “Biosimilars: SOP for Cross-Contamination Control in Bioreactor Operations – V 2.0” »

Biosimilars: SOP for Filter Integrity Testing in Bioreactor Operations – V 2.0 Standard Operating Procedure for Filter Integrity Testing in Bioreactor Operations for Biosimilars Department Biosimilars SOP No. SOP/BS/091/2025 Supersedes SOP/BS/091/2022 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 standard procedure for performing…

Read More “Biosimilars: SOP for Filter Integrity Testing in Bioreactor Operations – V 2.0” »