Tag: SOP for cell culture in biosimilar production

Biosimilars: SOP for Tangential Flow Filtration (TFF) Skid Operation – V 2.0

Posted on By

Biosimilars: SOP for Tangential Flow Filtration (TFF) Skid Operation – V 2.0 Standard Operating Procedure for Tangential Flow Filtration (TFF) Skid Operation in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/180/2025 Supersedes SOP/BS/180/2022 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…

Read More “Biosimilars: SOP for Tangential Flow Filtration (TFF) Skid Operation – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Ultrafiltration/Diafiltration (UF/DF) Process – V 2.0

Posted on By

Biosimilars: SOP for Ultrafiltration/Diafiltration (UF/DF) Process – V 2.0 Standard Operating Procedure for Ultrafiltration/Diafiltration (UF/DF) Process in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/179/2025 Supersedes SOP/BS/179/2022 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 performing Ultrafiltration/Diafiltration (UF/DF) of biosimilar drug…

Read More “Biosimilars: SOP for Ultrafiltration/Diafiltration (UF/DF) Process – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Hold Time Validation of Intermediate Products – V 2.0

Posted on By

Biosimilars: SOP for Hold Time Validation of Intermediate Products – V 2.0 Standard Operating Procedure for Hold Time Validation of Intermediate Products in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/178/2025 Supersedes SOP/BS/178/2022 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 validating…

Read More “Biosimilars: SOP for Hold Time Validation of Intermediate Products – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for In-Process Sample Collection During Purification – V 2.0

Posted on By

Biosimilars: SOP for In-Process Sample Collection During Purification – V 2.0 Standard Operating Procedure for In-Process Sample Collection During Purification in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/177/2025 Supersedes SOP/BS/177/2022 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 standard procedure for collecting in-process…

Read More “Biosimilars: SOP for In-Process Sample Collection During Purification – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Buffer Preparation for Purification Steps – V 2.0

Posted on By

Biosimilars: SOP for Buffer Preparation for Purification Steps – V 2.0 Standard Operating Procedure for Buffer Preparation for Purification Steps in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/176/2025 Supersedes SOP/BS/176/2022 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 GMP-compliant preparation,…

Read More “Biosimilars: SOP for Buffer Preparation for Purification Steps – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Integrity Testing of Viral Filters – V 2.0

Posted on By

Biosimilars: SOP for Integrity Testing of Viral Filters – V 2.0 Standard Operating Procedure for Integrity Testing of Viral Filters in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/175/2025 Supersedes SOP/BS/175/2022 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 validated procedure for performing integrity…

Read More “Biosimilars: SOP for Integrity Testing of Viral Filters – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Viral Filtration Using 20 nm Filters – V 2.0

Posted on By

Biosimilars: SOP for Viral Filtration Using 20 nm Filters – V 2.0 Standard Operating Procedure for Viral Filtration Using 20 nm Filters in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/174/2025 Supersedes SOP/BS/174/2022 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 GMP procedure…

Read More “Biosimilars: SOP for Viral Filtration Using 20 nm Filters – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Removal of Aggregates and Fragments – V 2.0

Posted on By

Biosimilars: SOP for Removal of Aggregates and Fragments – V 2.0 Standard Operating Procedure for Removal of Aggregates and Fragments in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/173/2025 Supersedes SOP/BS/173/2022 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 procedure for the removal…

Read More “Biosimilars: SOP for Removal of Aggregates and Fragments – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Reduction of Endotoxin Levels – V 2.0

Posted on By

Biosimilars: SOP for Reduction of Endotoxin Levels – V 2.0 Standard Operating Procedure for Reduction of Endotoxin Levels in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/172/2025 Supersedes SOP/BS/172/2022 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 reducing endotoxin levels in…

Read More “Biosimilars: SOP for Reduction of Endotoxin Levels – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Removal of Host Cell DNA – V 2.0

Posted on By

Biosimilars: SOP for Removal of Host Cell DNA – V 2.0 Standard Operating Procedure for Removal of Host Cell DNA in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/171/2025 Supersedes SOP/BS/171/2022 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 validated procedure for removing residual…

Read More “Biosimilars: SOP for Removal of Host Cell DNA – V 2.0” »

Biosimilars V 2.0