Standard Operating Procedure for Documentation of Clone Selection and Results in Biosimilar Development

Department	Biosimilars
SOP No.	SOP/BS/049/2025
Supersedes	SOP/BS/049/2022
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 system for documentation of clone selection, screening data, and related results to ensure data traceability, compliance, and reproducibility in biosimilar cell line development.

2. Scope

This SOP applies to all activities related to screening, selecting, and documenting clones during biosimilar product development, including ELISA, productivity assays, and cell bank selection.

3. Responsibilities

• Research Associates: Document clone IDs, assay data, and selection criteria in real time.
• Supervisors: Review clone selection records and approve final selection.
• QA Department: Verify documentation for compliance and audit readiness.

4. Accountability

The Head of Cell Line Development (CLD) is accountable for ensuring that all clone selection data is accurately documented and archived in accordance with regulatory guidelines.

5. Procedure

5.1 Clone Identification and Tracking

1. Assign a unique clone identification number as per CLD tracking format: e.g., CLD-CHO-001, CLD-HEK-045.
2. Record all clone identifiers in the Clone Master Register (Annexure-1).
3. Label all culture plates and flasks with corresponding clone ID, date, and analyst initials.

5.2 Screening Result Documentation

1. Record quantitative and qualitative assay results (e.g., ELISA, Western Blot, qPCR) in the Clone Screening Data Log (Annexure-2).
2. Include:
   • Assay method
   • Date of experiment
   • Test conditions
   • Raw and interpreted data

5.3 Selection Criteria Documentation

1. Define criteria used for selection (e.g., titer, stability, morphology).
2. Document selection decision rationale in the Clone Evaluation Summary Sheet (Annexure-3).
3. Cross-verify with target product profile and predefined CLD objectives.

5.4 Data Integrity Controls

1. Ensure all entries are made in ink, dated, and signed by responsible personnel.
2. Do not overwrite; use single line strike-out with reason initials and date.
3. Scan and archive all original records in a secured digital folder with version control.

5.5 Retention and Archival

1. Retain all clone development records for a minimum of 10 years or as per regulatory requirements.
2. QA to maintain an archival index and monitor environmental storage conditions.

6. Abbreviations

• CLD: Cell Line Development
• qPCR: Quantitative Polymerase Chain Reaction
• QA: Quality Assurance

7. Documents

1. Clone Master Register (Annexure-1)
2. Clone Screening Data Log (Annexure-2)
3. Clone Evaluation Summary Sheet (Annexure-3)

8. References

• ICH Q10 – Pharmaceutical Quality System
• WHO Guidelines on Quality, Safety, and Efficacy of Biotherapeutic Products
• 21 CFR Part 211 – Good Documentation Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Clone Master Register

Clone ID	Cell Type	Date Generated	Analyst	Remarks
CLD-CHO-017	CHO-K1	01/05/2025	Ajay Verma	High titer candidate

Annexure-2: Clone Screening Data Log

Clone ID	Assay	Result	Date	Tested By
CLD-CHO-017	ELISA	6.2 µg/mL	02/05/2025	Sunita Reddy

Annexure-3: Clone Evaluation Summary Sheet

Clone ID	Criteria Met	Selected (Yes/No)	Justification	Approved By
CLD-CHO-017	Expression > 5 µg/mL	Yes	Stable and productive	Vinay Pawar

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Enhanced data integrity requirements and archiving standards	Regulatory Alignment