Tag: cleanroom SOP for biologics manufacturing

Biosimilars: SOP for Clone Stability Assessment – V 2.0

Posted on By

Biosimilars: SOP for Clone Stability Assessment – V 2.0 Standard Operating Procedure for Clone Stability Assessment in Biosimilar Cell Line Development Department Biosimilars SOP No. SOP/BS/023/2025 Supersedes SOP/BS/023/2022 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 evaluating the genetic and phenotypic…

Read More “Biosimilars: SOP for Clone Stability Assessment – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Productivity Testing in Small-Scale Cultures – V 2.0

Posted on By

Biosimilars: SOP for Productivity Testing in Small-Scale Cultures – V 2.0 Standard Operating Procedure for Productivity Testing in Small-Scale Biosimilar Cultures Department Biosimilars SOP No. SOP/BS/022/2025 Supersedes SOP/BS/022/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the procedure for assessing productivity of biosimilar-expressing cell…

Read More “Biosimilars: SOP for Productivity Testing in Small-Scale Cultures – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Glycosylation Analysis in Clone Selection – V 2.0

Posted on By

Biosimilars: SOP for Glycosylation Analysis in Clone Selection – V 2.0 Standard Operating Procedure for Glycosylation Analysis in Biosimilar Clone Selection Department Biosimilars SOP No. SOP/BS/021/2025 Supersedes SOP/BS/021/2022 Page No. Page 1 of 15 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for analyzing glycosylation profiles of expressed…

Read More “Biosimilars: SOP for Glycosylation Analysis in Clone Selection – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Protein Expression Profiling – V 2.0

Posted on By

Biosimilars: SOP for Protein Expression Profiling – V 2.0 Standard Operating Procedure for Protein Expression Profiling in Biosimilar-Producing Cell Lines Department Biosimilars SOP No. SOP/BS/020/2025 Supersedes SOP/BS/020/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the procedure for evaluating biosimilar protein expression levels in…

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

Biosimilars V 2.0

Biosimilars: SOP for mRNA Transcript Analysis (RT-PCR) – V 2.0

Posted on By

Biosimilars: SOP for mRNA Transcript Analysis (RT-PCR) – V 2.0 Standard Operating Procedure for mRNA Transcript Analysis using RT-PCR in Biosimilar Development Department Biosimilars SOP No. SOP/BS/019/2025 Supersedes SOP/BS/019/2022 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 analyzing mRNA transcripts…

Read More “Biosimilars: SOP for mRNA Transcript Analysis (RT-PCR) – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Southern Blot Analysis – V 2.0

Posted on By

Biosimilars: SOP for Southern Blot Analysis – V 2.0 Standard Operating Procedure for Southern Blot Analysis in Biosimilar Cell Lines Department Biosimilars SOP No. SOP/BS/018/2025 Supersedes SOP/BS/018/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To define the method for performing Southern blot analysis for confirming…

Read More “Biosimilars: SOP for Southern Blot Analysis – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Gene Copy Number Determination – V 2.0

Posted on By

Biosimilars: SOP for Gene Copy Number Determination – V 2.0 Standard Operating Procedure for Gene Copy Number Determination in Biosimilar Cell Lines Department Biosimilars SOP No. SOP/BS/017/2025 Supersedes SOP/BS/017/2022 Page No. Page 1 of 13 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized method for determining the gene…

Read More “Biosimilars: SOP for Gene Copy Number Determination – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Adaptation of Cells to Serum-Free Media – V 2.0

Posted on By

Biosimilars: SOP for Adaptation of Cells to Serum-Free Media – V 2.0 Standard Operating Procedure for Adaptation of Cells to Serum-Free Media in Biosimilar Development Department Biosimilars SOP No. SOP/BS/016/2025 Supersedes SOP/BS/016/2022 Page No. Page 1 of 12 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To describe the step-by-step procedure for…

Read More “Biosimilars: SOP for Adaptation of Cells to Serum-Free Media – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Stable Cell Line Development – V 2.0

Posted on By

Biosimilars: SOP for Stable Cell Line Development – V 2.0 Standard Operating Procedure for Stable Cell Line Development in Biosimilar R&D Department Biosimilars SOP No. SOP/BS/015/2025 Supersedes SOP/BS/015/2022 Page No. Page 1 of 14 Issue Date 04/05/2025 Effective Date 06/05/2025 Review Date 04/05/2026 1. Purpose To establish a standardized procedure for the development of stable…

Read More “Biosimilars: SOP for Stable Cell Line Development – V 2.0” »

Biosimilars V 2.0

Biosimilars: SOP for Western Blotting for Protein Expression – V 2.0

Posted on By

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 V 2.0