Tag: SOP for bioreactor inoculation biosimilars

Biosimilars: SOP for Strong Cation Exchange Chromatography – V 2.0

Posted on By

Biosimilars: SOP for Strong Cation Exchange Chromatography – V 2.0 Standard Operating Procedure for Strong Cation Exchange Chromatography in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/160/2025 Supersedes SOP/BS/160/2022 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 performing strong cation exchange (SCX)…

Read More “Biosimilars: SOP for Strong Cation Exchange Chromatography – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Intermediate Purification via Ion-Exchange Chromatography – V 2.0

Posted on By

Biosimilars: SOP for Intermediate Purification via Ion-Exchange Chromatography – V 2.0 Standard Operating Procedure for Intermediate Purification via Ion-Exchange Chromatography in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/159/2025 Supersedes SOP/BS/159/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for performing intermediate purification…

Read More “Biosimilars: SOP for Intermediate Purification via Ion-Exchange Chromatography – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Buffer Exchange Using TFF – V 2.0

Posted on By

Biosimilars: SOP for Buffer Exchange Using TFF – V 2.0 Standard Operating Procedure for Buffer Exchange Using TFF in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/158/2025 Supersedes SOP/BS/158/2022 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 performing buffer exchange of biosimilar…

Read More “Biosimilars: SOP for Buffer Exchange Using TFF – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Viral Inactivation via Low pH Treatment – V 2.0

Posted on By

Biosimilars: SOP for Viral Inactivation via Low pH Treatment – V 2.0 Standard Operating Procedure for Viral Inactivation via Low pH Treatment in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/157/2025 Supersedes SOP/BS/157/2022 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 performing…

Read More “Biosimilars: SOP for Viral Inactivation via Low pH Treatment – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Elution and Regeneration of Protein A Column – V 2.0

Posted on By

Biosimilars: SOP for Elution and Regeneration of Protein A Column – V 2.0 Standard Operating Procedure for Elution and Regeneration of Protein A Column in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/156/2025 Supersedes SOP/BS/156/2022 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…

Read More “Biosimilars: SOP for Elution and Regeneration of Protein A Column – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Equilibration and Loading of Protein A Column – V 2.0

Posted on By

Biosimilars: SOP for Equilibration and Loading of Protein A Column – V 2.0 Standard Operating Procedure for Equilibration and Loading of Protein A Column in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/155/2025 Supersedes SOP/BS/155/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure…

Read More “Biosimilars: SOP for Equilibration and Loading of Protein A Column – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Protein A Affinity Chromatography Setup – V 2.0

Posted on By

Biosimilars: SOP for Protein A Affinity Chromatography Setup – V 2.0 Standard Operating Procedure for Protein A Affinity Chromatography Setup in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/154/2025 Supersedes SOP/BS/154/2022 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 GMP-compliant procedure for setting up…

Read More “Biosimilars: SOP for Protein A Affinity Chromatography Setup – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Pre-Filter and Sterile Filter Use – V 2.0

Posted on By

Biosimilars: SOP for Pre-Filter and Sterile Filter Use – V 2.0 Standard Operating Procedure for Pre-Filter and Sterile Filter Use in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/153/2025 Supersedes SOP/BS/153/2022 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 installation, use, and…

Read More “Biosimilars: SOP for Pre-Filter and Sterile Filter Use – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Centrifuge Operation for Cell Removal – V 2.0

Posted on By

Biosimilars: SOP for Centrifuge Operation for Cell Removal – V 2.0 Standard Operating Procedure for Centrifuge Operation for Cell Removal in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/152/2025 Supersedes SOP/BS/152/2022 Page No. Page 1 of 10 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To provide a detailed procedure for the operation…

Read More “Biosimilars: SOP for Centrifuge Operation for Cell Removal – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Harvest Clarification Using Depth Filtration – V 2.0

Posted on By

Biosimilars: SOP for Harvest Clarification Using Depth Filtration – V 2.0 Standard Operating Procedure for Harvest Clarification Using Depth Filtration in Biosimilar Manufacturing Department Biosimilars SOP No. SOP/BS/151/2025 Supersedes SOP/BS/151/2022 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 standardized procedure for clarifying harvested…

Read More “Biosimilars: SOP for Harvest Clarification Using Depth Filtration – V 2.0” »

Biosimilars V 2.0