Q5A(R2): viral safety evaluation of biotechnology products derived from cell lines of human or animal origin : guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Biologics Evaluation and Research (U.S.), issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2024
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biotechnology Cell Line Drug Industry Government Regulation Safety Virus Diseases United States
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance describes the evaluation of the viral safety of biotechnology products including viral clearance and testing, and it outlines what data should be submitted in marketing applications for those products. Biotechnology products include biotherapeutics and certain biological products derived from cell lines of human or animal origin (e.g., mammalian, avian, insect). In this guidance, the term virus excludes nonconventional transmissible agents like those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are encouraged to discuss transmissible spongiform encephalopathy associated issues with the appropriate regulatory authorities because they are not in scope of this guidance. This guidance includes products such as cytokines, monoclonal antibodies (mAbs), and subunit vaccines produced from in vitro cell culture using recombinant DNA technologies. This guidance also includes certain genetically engineered viral vectors and viral vector-derived products (e.g., viral vaccines, gene therapy products), provided they are amenable to viral clearance, without a negative effect on the product. These products can include viral vectors, for example, adeno-associated virus (AAV), produced using transient or stable transfected cell lines, or by infection using a recombinant virus. It also includes viral vector-derived products, for example, baculovirus-expressed virus-like particles (VLPs), protein subunits, and nanoparticle-based protein vaccines and therapeutics. AAV gene therapy vectors include those that depend on helper viruses such as herpes simplex virus or adenovirus for their production. Specific guidance on genetically engineered viral vectors and viral vector-derived products is provided in Appendix F (Annex 6).
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 53 pages))
- NLM Unique ID:
- 9918751182106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918751182106676