Main Regulations for Adventitious Agents Applicable to Biological Products
| Regulations | Scope |
|---|---|
| FDA Guidance for Industry (February 2010). Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (4) | Cell substrates of human and animal (including insect) origin, viral seeds and other biological materials (including vaccine intermediates), live attenuated preparations of viruses, inactivated (killed) whole or subunit virions, purified recombinant proteins, synthetic antigens, or live viral vectors expressing specific heterologous vaccine antigens |
| FDA Points to Consider in the Characterization of Cell Lines Used To Produce Biologicals (1993) (5) | Monoclonal antibodies (and previously vaccines) |
| FDA Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (1997) (6) | Monoclonal antibodies |
| ICH Harmonised Tripartite Guideline Q5A (September 1999). Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (2) | Includes products derived from in vitro cell cultures, such as interferons, monoclonal antibodies, and recombinant DNA-derived products including recombinant subunit vaccines; excludes inactivated vaccines, all live vaccines, and genetically engineered live vectors |
| Ph. Eur. Chapter 5.2.3—Cell Substrates for the Production of Vaccines for Human Use, 8th ed.; 2013 (7) | Diploid cell lines and continuous cell lines used for the production of vaccines for human use |
| Ph. Eur. Chapter 2.6.16—Tests for Extraneous Agents in Viral Vaccines for Human Use, 8th ed., 2013 (8) | Viral seeds and harvests (including control cells and control eggs) manufactured on animals cells (including avian, human, and insect cells) and on eggs |
| WHO. Recommendations for the evaluation of animal cell cultures as cell substrates for the manufacture of biological medicinal products and for the characterization of cell banks—TRS 978, Annex 3, 2013, adopted by the Expert Committee on Biological Standardization (ECBS), Oct 2010** (1) | Animal cell substrates for the production of biological medicinal products (vaccines and monoclonal antibodies are then included) |
↵** Specific requirements for vaccines are also available in each vaccine-specific TRS.