Visible and subvisible particulates, silicone oil, and container selection can have an impact on the degradation of large protein molecules leading to denaturation and concerns for patient safety
Biopharmaceuticals and Biosimilars are at the forefront of parenteral drug development providing improved patient lives from debilitating and chronic diseases. Administration of these therapeutic drugs through self-administration is typically provided by combination devices such as prefilled syringes and large volume injection devices.
The sensitivity of these therapeutic drugs to silicone oil, liquid-air interfaces, and particulates is well documented in research, regulatory guidelines, and by the pharmaceutical industry. The choice of container becomes an important exercise in improving the efficacy of the drug product and reducing the risk of an immunogenic response.
This webinar will explore current research on the impact of visible and subvisible particulates, silicone oil, and container materials on patient immunogenic response and protein denaturation. The discussion will also provide some insight into regulatory guidelines and USP updates that address the concerns of sensitive biotherapeutics.
Presented by
Kevin Constable,
Sr. Director, Technology Development
Mr. Constable joined Terumo Medical Corporation in January 2012 to lead the Technology Development team for Terumo Pharmaceutical Solutions Division providing drug & device solutions to the pharmaceutical industry.
Prior to Terumo Mr. Constable was employed by Pfizer working in the vaccines / biotechnology sector supporting technology transfer of biotech drug products, the global launch of a pediatric vaccine, risk mitigation of supply, improved process solutions for filling and packaging, track and trace solutions, and global harmonization of practices for aseptic filling, inspection, lyophilization, and packaging of pre-filled syringes and vials. Mr. Constable has over 20 years of experience in the pharmaceutical industry.
John Carpenter, PhD.,
Professor of Pharmaceutical Sciences and Co-Director of the Center for Pharmaceutical Biotechnology
John F. Carpenter is a Professor of Pharmaceutical Sciences at the University of Colorado (CU) and Co-Director of the CU Center for Pharmaceutical Biotechnology. His research focuses on mechanisms for protein degradation and stabilization. John has published >270 peer-reviewed papers and holds more than 30 patents.
He is an Editor for the Journal of Pharmaceutical Sciences and serves on several Editorial Advisory Boards. He has received The Ebert Prize and the American Association of Pharmaceutical Scientists (AAPS) Research Achievement Award in Biotechnology. He is a Fellow of the American Association for Advancement of Science, the AAPS and the National Academy of Inventors.
