Enabling Efficient Design of Biological Formulations through Advanced Characterizations

Affiliations

• ¹ Division of Complex Drug Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, 20993, USA.
• ² Biologics Analytical Research and Development, Analytical Research and Development, Merck & Co., Inc., Kenilworth, NJ, 07033, USA.
• ³ Analytical Research and Development, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc., Andover, MA, 01810, USA.
• ⁴ Analytical Development and Attribute Sciences, Bristol Myers Squibb, New Brunswick, NJ, 08901, USA.
• ⁵ Center for Pharmaceutical Biotechnology, Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, USA.
• ⁶ Analytical Enabling Capabilities, Analytical Research and Development, Merck & Co., Inc., Rahway, NJ, 07065, USA. yongchao.su@merck.com.
• ⁷ Sterile and Specialty Products, Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Kenilworth, NJ, 07033, USA. yongchao.su@merck.com.