SOP Guide for Pharma

Biosimilars: SOP for Selection of Host Cell Lines – V 2.0

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Biosimilars: SOP for Selection of Host Cell Lines – V 2.0


Standard Operating Procedure for Selecting Host Cell Lines in Biosimilar Manufacturing

Department Biosimilars
SOP No. SOP/BS/001/2025
Supersedes SOP/BS/001/2022
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 procedure for selecting host cell lines such as CHO, HEK293, and E. coli for the development of biosimilars, ensuring high productivity, regulatory compliance, and reproducibility.

2. Scope

This SOP applies to all personnel in the Biosimilars department involved in the selection, evaluation, and documentation of host cell lines during early-stage biosimilar development.

3. Responsibilities

See also  Biosimilars: SOP for Creation of Working Cell Bank (WCB) - V 2.0

4. Accountability

The Head of Biosimilars is accountable for ensuring compliance with this SOP and the scientific and regulatory appropriateness of the host cell lines selected.

5. Procedure

5.1 Define Product Requirements

  1. Identify the biosimilar product type: e.g., monoclonal antibody, cytokine, or hormone.
  2. Define requirements for post-translational modifications such as glycosylation.
  3. Establish expression yield targets based on commercial-scale requirements.

5.2 Compile List of Candidate Host Cell Lines

  1. Generate a list of commonly used host cell lines:
    • CHO (Chinese Hamster Ovary)
    • HEK293 (Human Embryonic Kidney)
    • E. coli (for prokaryotic expression)
  2. Assess each host cell line based on:
    • Scalability
    • Doubling time and metabolic efficiency
    • Post-translational modification capabilities
    • Availability of safety and lineage documentation

5.3 Perform Feasibility Experiments

  1. Perform small-scale transfection experiments with model constructs.
  2. Measure protein expression levels using ELISA or SDS-PAGE.
  3. Record findings in the Host Cell Screening Log (Annexure-1).

5.4 Review Regulatory and Biosafety Compliance

  1. Check biosafety levels (BSL-1 or BSL-2) of selected cell lines.
  2. Ensure the availability of cell bank Certificate of Analysis (CoA).
  3. Verify compliance with ICH Q5D, WHO TRS 978, and CDSCO requirements.
See also  Biosimilars: SOP for Restriction Enzyme Digestion and Mapping - V 2.0

5.5 Final Selection and Approval

  1. Consolidate all experimental, regulatory, and biosafety data.
  2. Complete the Host Cell Line Selection Form (Annexure-2).
  3. Submit the form for cross-functional review and approval.

5.6 Documentation

  1. Update the Host Cell Line Master List (Annexure-3).
  2. File all relevant data in the Cell Line Selection Master File.

6. Abbreviations

7. Documents

  1. Host Cell Screening Log (Annexure-1)
  2. Host Cell Line Selection Form (Annexure-2)
  3. Host Cell Line Master List (Annexure-3)

8. References

See also  Biosimilars: SOP for Protein Expression Profiling - V 2.0

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Host Cell Screening Log

Date Cell Line Transfection Method Expression Yield Remarks
22/04/2025 CHO-K1 Electroporation Medium Good viability
23/04/2025 HEK293 PEI High Selected
24/04/2025 E. coli DH5α Heat Shock Very High No glycosylation

Annexure-2: Host Cell Line Selection Form

Selected Cell Line HEK293
Justification High expression yield and compatible glycosylation
Date of Selection 26/04/2025
Cross-Functional Review Team QA, RA, R&D

Annexure-3: Host Cell Line Master List

Cell Line Type BSL Source CoA No.
HEK293 Mammalian BSL-2 ATCC HEK2025-01
CHO-K1 Mammalian BSL-1 Thermo Fisher CHO2025-02
E. coli DH5α Prokaryotic BSL-1 NCIM EC2025-05

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
04/05/2025 2.0 Revised and reissued SOP under version 2.0 Annual review and update
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