Surfactants in Biopharmaceutical Development

Atanas V. Koulov is the Head of Analytical Development and Quality Control, Drug Product Services at Lonza in Switzerland. His scientific career has focused on surfactants as protective excipients and includes eight years of work in the biopharmaceutical industry. Dr. Koulov’s research is primarily concerned with understanding and preventing aggregation, as well as measuring and characterizing undesired byproducts of surfactant degradation. Dr. Koulov has co-organized and participated in symposia and conference sessions dedicated to surfactants. He has published extensively in the field of protein aggregation and particles and is the immediate past chair of the American Association of Pharmaceutical Scientists Protein Aggregation & Biological Consequences Focus Group. Satish K. Singh has more than 25 years of experience in biopharmaceutical product development. His expertise includes process development, scale-up and technology transfer and ranges from discovery support to development, manufacture and final drug product commercialization.Prior to joining Lonza, Satish was a Research Fellow and Group Leader in Pfizer's Biotherapeutics Pharmaceutical Sciences R&D Unit. Satish has also lead technical teams that focused on particulates, drug substance storage, antibody drug conjugate structure/property relationship, immunogenicity risk evaluation, and the development and application of computational tools in the chemistry, manufacturing and controls (CMC) aspects of biotherapeutics. Satish holds a Ph.D. and MS in Chemical Engineering from Kansas State University and a B.Tech. in Chemical Engineering from the Indian Institute of Technology, New Delhi, India. He has published more than 70 scientific publications on various topics related to the field and is also an Adjunct Professor in the Department of Physical Pharmaceutical Chemistry, BMC, Uppsala University, Sweden. In 2017, Satish was elected an American Association of Pharmaceutical Scientists(AAPS) Fellow in recognition of his contributions to AAPS and drug product development.

1. Introduction 2. Polysorbate Surfactants used in biopharmaceuticals: An overview including in vivo fate and toxicology perspective 3. Surfactants (polysorbate and poloxamer) synthesis and degradation: Overview and relevance 4. Mechanisms of stabilization of proteins by surfactants 5. Behaviour of surfactant during processing (UF/DF, filter adsorption) 6. Analytical methods for surfactant characterization in Drug Product 7. Oxidative degradation of surfactants: Mechanisms 8. Hydrolytic degradation of surfactants and impact on protein stabilization 9. Regulatory Perspective on Surfactant Monitoring and Control 10. Control strategies to address surfactant degradation: A quality perspective 11. A look to the future - closing remarks