The authors would like to thank Patricia Hughes and Kalavati Suvarna, both from FDA, for helpful discussions regarding this
ANASTASIA G. LOLAS (not pictured) is president of Visionary Pharma Consulting, Olney, MD, and ANURAG S. RATHORE, PHD*, is a consultant at Biotech CMC Issues and a member of the faculty in the department of chemical engineering at the Indian
Institute of Technology. Rathore is also a member of BioPharm International's Editorial Advisory Board.
*To whom correspondence should be addressed, firstname.lastname@example.org
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