Tag: GMP SOP for biosimilars

Biosimilars: SOP for Western Blotting for Protein Expression – V 2.0 Standard Operating Procedure for Western Blotting for Protein Expression in Biosimilar Cell Clones Department Biosimilars SOP No. SOP/BS/014/2025 Supersedes SOP/BS/014/2022 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 standardized procedure for detecting…

Read More “Biosimilars: SOP for Western Blotting for Protein Expression – V 2.0” »

Biosimilars: SOP for ELISA-Based Screening of Clones – V 2.0 Standard Operating Procedure for ELISA-Based Screening of Clones in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/013/2025 Supersedes SOP/BS/013/2022 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 method for using Enzyme-Linked Immunosorbent Assay…

Read More “Biosimilars: SOP for ELISA-Based Screening of Clones – V 2.0” »

Biosimilars: SOP for Colony Screening and Expression Analysis – V 2.0 Standard Operating Procedure for Colony Screening and Expression Analysis in Biosimilar Cell Line Development Department Biosimilars SOP No. SOP/BS/012/2025 Supersedes SOP/BS/012/2022 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 standardized method for…

Read More “Biosimilars: SOP for Colony Screening and Expression Analysis – V 2.0” »

Biosimilars: SOP for Limiting Dilution Cloning – V 2.0 Standard Operating Procedure for Limiting Dilution Cloning in Biosimilar Development Department Biosimilars SOP No. SOP/BS/011/2025 Supersedes SOP/BS/011/2022 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 a standard procedure for isolating single-cell-derived clones by limiting dilution…

Read More “Biosimilars: SOP for Limiting Dilution Cloning – V 2.0” »

Biosimilars: SOP for Selection of Stably Transfected Clones – V 2.0 Standard Operating Procedure for Selection of Stably Transfected Clones in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/010/2025 Supersedes SOP/BS/010/2022 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 process for selecting, isolating, and…

Read More “Biosimilars: SOP for Selection of Stably Transfected Clones – V 2.0” »

Biosimilars: SOP for Transient Transfection Methods – V 2.0 Standard Operating Procedure for Transient Transfection Methods in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/009/2025 Supersedes SOP/BS/009/2022 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 procedure for transient transfection of mammalian cells using lipid-mediated…

Read More “Biosimilars: SOP for Transient Transfection Methods – V 2.0” »

Biosimilars: SOP for Agarose Gel Electrophoresis – V 2.0 Standard Operating Procedure for Agarose Gel Electrophoresis in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/008/2025 Supersedes SOP/BS/008/2022 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 agarose gel electrophoresis to separate,…

Read More “Biosimilars: SOP for Agarose Gel Electrophoresis – V 2.0” »

Biosimilars: SOP for Restriction Enzyme Digestion and Mapping – V 2.0 Standard Operating Procedure for Restriction Enzyme Digestion and Mapping in Biosimilar Research Department Biosimilars SOP No. SOP/BS/007/2025 Supersedes SOP/BS/007/2022 Page No. Page 1 of 11 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standard method for performing restriction…

Read More “Biosimilars: SOP for Restriction Enzyme Digestion and Mapping – V 2.0” »

Biosimilars: SOP for Plasmid Amplification and Purification – V 2.0 Standard Operating Procedure for Plasmid Amplification and Purification in Biosimilar Development Department Biosimilars SOP No. SOP/BS/006/2025 Supersedes SOP/BS/006/2022 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 process for amplifying and purifying plasmid DNA…

Read More “Biosimilars: SOP for Plasmid Amplification and Purification – V 2.0” »

Biosimilars: SOP for Transformation and Electroporation – V 2.0 Standard Operating Procedure for Transformation and Electroporation in Biosimilar Development Department Biosimilars SOP No. SOP/BS/005/2025 Supersedes SOP/BS/005/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To outline the standardized procedure for introducing recombinant plasmids into host cells…

Read More “Biosimilars: SOP for Transformation and Electroporation – V 2.0” »