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
- Clones selected for archival must:
- Show stable expression and viability ≥90%
- Be confirmed via ELISA and microscopic observation
- Label cryovials with:
- Clone ID
- Date of freezing
- Passage number
- Scientist initials
- Freeze vials using a controlled rate freezer and transfer to vapor-phase LN2 tanks.
5.2 Inventory Registration
- Each archived clone entry must be logged in the Clone Inventory Register (Annexure-1).
- Include:
- Clone description
- Vector system
- Passage details
- Freezer ID and rack location
5.3 Storage Location Control
- Designate freezer zones with unique codes (e.g., LN2-F1, R1-S2-B4).
- Maintain a freezer map updated monthly with QA review.
5.4 Retrieval and Re-archival
- Log every vial withdrawal in Clone Access Log (Annexure-2) with:
- Date and purpose
- Retrieving person and authorizing scientist
- Re-archived vials must have a new ID extension (e.g., CL-42A-R1).
5.5 Periodic Review
- Every 6 months, review archival clones for:
- Viability
- Relevance to current projects
- Document review findings in the Archival Review Log (Annexure-3).
6. Abbreviations
- LN2: Liquid Nitrogen
- CLD: Cell Line Development
- QA: Quality Assurance
7. Documents
- Clone Inventory Register (Annexure-1)
- Clone Access Log (Annexure-2)
- 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 |