1. Chapter 3: CMC Activities for Monoclonal Antibody Development, in H.L. Levine, G. Jagschies (Eds.), The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities from Clone to Clinic, Sweden, 2010, pp. 36–59.
2. ICH Q8 Pharmaceutical Development Step 4. ICH Harmonised Tripartite Guideline, Q8, 2009, pp. 1–28.
3. FDA, Process Validation: General Principles and Practices U.S.D.o.H.a.H.S.F.a.D. Administration, Editor, 2011.
4. ICH, ICH guideline Q8 (R2) on pharmaceutical development: Step 5, in EMA/CHMP/ICH/167068/2004, E.M. Agency (Ed.), Committee for Human Medicinal Products, 2015.
5. 3—Process-design concepts;Hagel,2008