1. Center for Biologics Evaluation and Research(1997).Points to consider in the manufacture and testing of monoclonal antibody products for human use.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/points-consider-manufacture-and-testing-monoclonal-antibody-products-human-use
2. European Medicines Agency(2008).Guideline on virus safety evaluation of biotechnological investigational medicinal products.https://www.ema.europa.eu/en/virus-safety-evaluation-biotechnological-investigational-medicinal-products
3. Office of Medical Products and Tobacco Center for Biologics Evaluation and Research(1998).Q5A viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q5a-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin
4. Recent Developments in Bioprocessing of Recombinant Proteins: Expression Hosts and Process Development
5. Optimization of a micro-scale, high throughput process development tool and the demonstration of comparable process performance and product quality with biopharmaceutical manufacturing processes