Subvisible Particles Matter, Developments in Regulations and Low Volume Methods

26th July 2018 | 10AM EST | Dr Satish K Singh, Lonza |WATCH FOR FREE

The need to measure and characterize proteinaceous particles in therapeutic protein products has been emphasized by regulators. USP<787> is a new chapter that addresses the limitations of USP<788> for therapeutic proteins in measurement of subvisible particles. USP<1787> is a guidance chapter addressing the task of characterization of particles with the emphasis on proteinaceous particles. Furthermore, regulatory authorities require that sponsors understand the submicron particle size range of the products also. This article will look at latest regulatory developments, key aspects of the measurement of subvisible and submicron particles in biotherapeutics, as well as the utility of low volume methods.

Presented by Dr Satish K Singh, Lonza

Dr. Satish Singh is Head of Drug Product Process Development, in the Drug Product Services group at Lonza Pharma and Biotech, where he is leading the drug process development and characterization capabilities. Prior to joining Lonza in Sept2016, Satish was Research Fellow and Group Leader at Pfizer’s BioTherapeutics Pharmaceutical R&D unit. Satish has more than 25 years’ experience in the industry in product development activities, and is an internationally recognized expert in all aspects of (bio)pharmaceutical Drug Product (biologics, vaccines) development. His experience includes ophthalmics and parenterals, encompassing primarily biologics but also small molecules, and he has been involved in the submission of several BLAs and INDs. Satish has a strong technical background, complemented by a deep understanding of regulatory challenges and the evolving regulatory landscape, and has more than 70 scientific publications in the field. He is involved in various professional groups through the AAPS as well as the USP and was a member of the expert panel that wrote USP<787> and <1787>. His research interests also include the investigation of impact of freezing processes on proteins, use of computational approaches to mitigate develop-ability issues, and aggregation and immunogenicity. He obtained his B.Tech from the Indian Institute of Technology, New Delhi, and an M.S. and Ph.D. in Chemical Engineering from Kansas State University. He holds the position of Adjunct Professor at the Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden.

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