Standard Operating Procedure for Clone Archival and Inventory Management in Biosimilar R&D

Department	Biosimilars
SOP No.	SOP/BS/042/2025
Supersedes	SOP/BS/042/2022
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 uniform and traceable procedure for the archival and inventory management of biosimilar-producing clones, ensuring secure storage, proper labeling, and ease of retrieval for future use in compliance with data integrity and GMP principles.

2. Scope

This SOP applies to all biosimilar R&D facilities engaged in clone banking, storage of stably transfected cells, and clone inventory management during upstream and downstream development stages.

3. Responsibilities

• Cell Line Development Team: Archives clones following documentation and quality checks.
• QA Representative: Reviews logs and ensures alignment with regulatory expectations.
• Inventory Manager: Maintains real-time electronic and physical inventory of clone vials.

4. Accountability

The Head of Biosimilar Development is accountable for ensuring systematic archival and secure inventory control of biosimilar clones with traceable documentation.

5. Procedure

5.1 Clone Freezing and Storage

1. Clones selected for archival must:
   • Show stable expression and viability ≥90%
   • Be confirmed via ELISA and microscopic observation
2. Label cryovials with:
   • Clone ID
   • Date of freezing
   • Passage number
   • Scientist initials
3. Freeze vials using a controlled rate freezer and transfer to vapor-phase LN2 tanks.

5.2 Inventory Registration

1. Each archived clone entry must be logged in the Clone Inventory Register (Annexure-1).
2. Include:
   • Clone description
   • Vector system
   • Passage details
   • Freezer ID and rack location

5.3 Storage Location Control

1. Designate freezer zones with unique codes (e.g., LN2-F1, R1-S2-B4).
2. Maintain a freezer map updated monthly with QA review.

5.4 Retrieval and Re-archival

1. Log every vial withdrawal in Clone Access Log (Annexure-2) with:
   • Date and purpose
   • Retrieving person and authorizing scientist
2. Re-archived vials must have a new ID extension (e.g., CL-42A-R1).

5.5 Periodic Review

1. Every 6 months, review archival clones for:
   • Viability
   • Relevance to current projects
2. Document review findings in the Archival Review Log (Annexure-3).

6. Abbreviations

• LN2: Liquid Nitrogen
• CLD: Cell Line Development
• QA: Quality Assurance

7. Documents

1. Clone Inventory Register (Annexure-1)
2. Clone Access Log (Annexure-2)
3. Archival Review Log (Annexure-3)

8. References

• ICH Q5D – Derivation and Characterization of Cell Substrates
• WHO Technical Report Series No. 978
• Data Integrity ALCOA+ Guidelines

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 Inventory Register

Clone ID	Date	Passage	Location	Scientist
CL-42A	02/05/2025	P12	LN2-F1-R2-B1	Ajay Verma

Annexure-2: Clone Access Log

Date	Clone ID	Reason	Retrieved By	Authorized By
03/05/2025	CL-42A	Process optimization	Sunita Reddy	Rajesh Kumar

Annexure-3: Archival Review Log

Date	Clone ID	Viability (%)	Review Outcome	Remarks
01/05/2025	CL-42A	93%	Retain	Still relevant

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
04/05/2025	2.0	Added freezer map and re-archival tracking	Inventory Control Enhancement