Standard Operating Procedure for Risk Assessment in Genetic Engineering for Biosimilar Development
| Department | Biosimilars |
|---|---|
| SOP No. | SOP/BS/039/2025 |
| Supersedes | SOP/BS/039/2022 |
| 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 systematic procedure for risk assessment associated with genetic engineering operations during biosimilar development, including evaluation of biological hazards, vector-host systems, gene inserts, and containment strategies in accordance with applicable biosafety and regulatory guidelines.
2. Scope
This SOP applies to all genetic engineering activities conducted in the biosimilars R&D laboratories, including transfection, vector design, GMO handling, and gene expression studies involving recombinant DNA technologies.
3. Responsibilities
- Principal Investigator: Initiates risk assessment, classifies genetic work, and obtains IBSC approval.
- Biosafety Officer: Reviews and verifies risk control measures; maintains risk logs and approvals.
- QA Personnel: Audits compliance with risk assessment SOP and maintains documentation.
4. Accountability
The R&D Head is accountable for ensuring all genetic engineering activities are reviewed for risk prior to execution, and proper containment, PPE, and documentation are in place.
5. Procedure
5.1 Risk Categorization of Genetic Work
- Identify the biological material used:
- Host organism (e.g., CHO, E. coli, HEK293)
- Donor DNA (e.g., antibody, cytokine)
- Vector type (plasmid, viral)
- Classify the experiment under:
- Category I: Minimal risk
- Category II: Moderate risk requiring IBSC approval
- Category III: High-risk requiring RCGM review
- Document classification using the Genetic Work Risk Log (Annexure-1).
5.2 Hazard Identification
- Evaluate potential risks including:
- Allergenicity or toxicity of gene product
- Resistance marker (e.g., antibiotic resistance)
- Pathogenic potential of host-vector system
5.3 Containment and Control Measures
- For Category I/II experiments, implement:
- BSL-2 containment
- Work inside biosafety cabinet
- Autoclaving of waste
- Prepare SOPs for PPE, disinfection, and transport of GMOs.
- Use containment checklist (Annexure-2) before beginning work.
5.4 Approval Process
- Submit Genetic Engineering Risk Assessment Form (Annexure-3) to IBSC.
- Await written clearance before initiating experiments.
5.5 Training and Awareness
- All personnel involved in genetic engineering must:
- Complete biosafety training annually
- Sign awareness and compliance statement (Annexure-4)
6. Abbreviations
- IBSC: Institutional Biosafety Committee
- RCGM: Review Committee on Genetic Manipulation
- GMO: Genetically Modified Organism
- BSL-2: Biosafety Level 2
7. Documents
- Genetic Work Risk Log (Annexure-1)
- Containment Compliance Checklist (Annexure-2)
- Genetic Engineering Risk Assessment Form (Annexure-3)
- Personnel Biosafety Declaration (Annexure-4)
8. References
- Rules 1989 under EPA for GMO regulation in India
- NIH Guidelines for Recombinant DNA Molecules
- WHO Biosafety Manual (4th Edition)
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Genetic Work Risk Log
| Date | Experiment ID | Host | Vector | Gene Insert | Category | Risk Status |
|---|---|---|---|---|---|---|
| 03/05/2025 | GE-039-01 | CHO | pcDNA3.1 | mAb Gene | II | Moderate |
Annexure-2: Containment Compliance Checklist
| Item | Checked | Remarks |
|---|---|---|
| BSL-2 Facility Available | Yes | Certified |
| Autoclave Available | Yes | On-site |
| Spill Kit Ready | Yes | Inside Lab |
Annexure-3: Genetic Engineering Risk Assessment Form
| Experiment Title | CHO Cell Line Engineering |
|---|---|
| Principal Investigator | Dr. Sunita Reddy |
| Gene Product | Monoclonal Antibody |
| Vector | pcDNA3.1 |
| Host Cell | CHO-K1 |
| Risk Category | II |
| Containment | BSL-2 |
Annexure-4: Personnel Biosafety Declaration
| Name | Department | Training Completed On | Signature |
|---|---|---|---|
| Ajay Verma | CLD | 01/03/2025 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 04/05/2025 | 2.0 | Added NIH and WHO references and updated Annexures | Process alignment with biosafety standards |