Standard Operating Procedure for Transport of Cell Banks in Biosimilar Manufacturing
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/053/2025 |
| Supersedes | SOP/BS/053/2022 |
| 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 validated, secure, and compliant method for the transportation of Master Cell Bank (MCB) and Working Cell Bank (WCB) materials from one facility to another within or outside the organization, ensuring viability, identity, and containment during transit.
2. Scope
This SOP applies to all biosimilar MCB and WCB materials prepared by the CLD team that are to be transported between research labs, contract manufacturing organizations (CMOs), testing labs, or internal storage sites.
3. Responsibilities
- CLD Personnel: Prepare, document, and package the cell banks for transport.
- QA Department: Approves dispatch documentation and verifies chain of custody.
- Logistics Team: Ensures validated cold chain handling and timely delivery.
4. Accountability
The Head of QA is accountable for ensuring all aspects of transport—including labeling, documentation, validation, and temperature control—are in compliance with GMP and biosafety guidelines.
5. Procedure
5.1 Pre-Transport Preparation
- Confirm the identity and quantity of MCB/WCB vials to be transported using the Cell Bank Inventory Sheet (Annexure-1).
- Ensure the receiving site has appropriate facilities and written confirmation for receipt.
- Complete the Cell Bank Transport Authorization Form (Annexure-2) and obtain QA approval before dispatch.
5.2 Packaging Requirements
- Use certified cryogenic shipping containers or validated dry shippers pre-cooled with liquid nitrogen.
- Place MCB/WCB vials in labeled secondary containment within the shipper. Each vial should be individually coded and protected against breakage.
- Include calibrated temperature data logger to record temperature during transit.
- Seal the outer container with tamper-evident tape. Affix biohazard label and “Handle with Care – Frozen Biological Material” notice on visible sides.
5.3 Transport Conditions and Logistics
- Only approved logistics vendors trained in handling biological materials must be used.
- Transport route and time window should be pre-approved. Avoid customs delays for international transport.
- Ensure compliance with applicable IATA regulations and biosafety Level 2 transport standards.
5.4 Documentation During Transit
- Include the following in the shipment:
- Transport Authorization Form
- Temperature Monitoring Certificate
- Material Safety Data Sheet (MSDS)
- Receiving Site Confirmation Letter
- Update Chain of Custody Log (Annexure-3) at each transit point.
5.5 Receipt at Destination
- Receiving site shall verify:
- Integrity of the shipper
- Temperature log data
- Vial condition and label match
- Complete the Cell Bank Receipt Report (Annexure-4) and return a signed copy to the QA team.
5.6 Deviation Management
- Any breach in temperature range, physical damage, or delay must be reported as a deviation using the QA Deviation Form.
- QA shall investigate and assess impact on cell viability before use.
6. Abbreviations
- MCB: Master Cell Bank
- WCB: Working Cell Bank
- QA: Quality Assurance
- IATA: International Air Transport Association
7. Documents
- Cell Bank Inventory Sheet (Annexure-1)
- Cell Bank Transport Authorization Form (Annexure-2)
- Chain of Custody Log (Annexure-3)
- Cell Bank Receipt Report (Annexure-4)
8. References
- WHO Guidelines on Biological Transport
- IATA Dangerous Goods Regulations
- 21 CFR Part 211 – Distribution Records
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cell Bank Inventory Sheet
| Cell Bank ID | Vial Count | Freezer Location | Prepared By | Date |
|---|---|---|---|---|
| MCB-CHO-017 | 100 | LN2-Freezer-02 | Ajay Verma | 02/05/2025 |
Annexure-2: Cell Bank Transport Authorization Form
| Transport Date | Destination | Authorized By | QA Approval |
|---|---|---|---|
| 04/05/2025 | QA Archives, Hyderabad | Sunita Reddy | Vinay Pawar |
Annexure-3: Chain of Custody Log
| Step | Handled By | Date | Time | Signature |
|---|---|---|---|---|
| Dispatch | Ajay Verma | 04/05/2025 | 10:00 | |
| Delivery | Logistics (FedEx Bio) | 04/05/2025 | 14:45 |
Annexure-4: Cell Bank Receipt Report
| Received By | Date | Condition | Temperature Range | Remarks |
|---|---|---|---|---|
| Rahul Joshi | 04/05/2025 | Intact | -150°C to -196°C | Data logger attached |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Expanded cold chain validation and international transport protocols | Compliance with WHO/IATA |