1. Antibody production;Birch;Adv Drug Deliv Rev,2006
2. Guidance for Industry, PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance;Food and Drug Administration,2004
3. Q11 development and manufacture of drug sustances (Chemical entities and biotechnological/biological entities);ICH Harmonised Tripartite Guidelines;ICH Harmon Guidel,2012
4. Q8(R2) pharmaceutical development;ICH Harmonised Tripartite Guidelines;ICH Harmon Guidel,2009
5. QbD/PAT for bioprocessing: moving from theory to implementation;Rathore;Curr Opin Chem Eng,2014