1. CMC Biotech Working Group. A-Mab: a case study in bioprocess development. Version 2.1, 30 Oct 2009; 2009.
2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH harmonized tripartite guideline: pharmaceutical development Q8(R2); 2009. Available at:
https://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
.
3. Antonsen HR, et al. Sterilizing filtration of liquids. Technical report no. 26. PDA J Pharm Sci Technol. 2008;62(5 Suppl TR26):2–60.
4. FDA Pharmaceutical cGMP. Guidance for industry: sterile drug products produced by aseptic processing — Current good manufacturing practice; September, 2004.
5. European Pharmacopeia, Ph.Eur. 9.0.