DC Discussion Group
With the origins of CASSS in mind, the DC Area Scientific Discussion Group offers an opportunity for CASSS members to meet others who understand what they do in an informal setting and exchange new ideas. They have been bringing people in the field of biotechnology and biopharmaceutical development together since 2014. This group’s mission is "Bringing Together Industrial Challenges in the Development of Biologics with Advances in Science and Technology." Anyone in the greater DC/Maryland area (or for virtual meetings, anyone around the world) affiliated with biotechnology, or interested in learning more about the scientific and technological applications to biotechnology is invited to attend.
Role of Risk Assessment in Advanced Technologies | September 14, 2022 11:00 - 12:30 EDT
Biologics and vaccine development and commercial manufacturing have occasionally been disrupted by the introduction of new analytical technologies or by the lack thereof. The use of increasingly more sensitive technologies brought to light contaminants that were previously missed. For example, the introduction of product-enhanced reverse-transcriptase (PERT) resulted in detection of ancient avian retroviral particles in a live virus vaccine produced in chicken embryos, and porcine circovirus was found by next generation sequencing in vaccines produced using trypsin in the manufacturing process. Conversely, adverse events have arisen from the failure of analytical testing to distinguish the intended product from a substitute as was the case when deliberately adulterated heparin went undiscovered until alternate technologies were employed. Talks in this session will describe some of these experiences and efforts by industry and regulators to better ensure the quality of biological products.
Jean-Pol Cassart from GlaxoSmithKline Pharmaceuticals s.a/n.v, Belgium’s Viral Safety Program will address the investigation into PCV-1 contamination of GSK’s rotavirus vaccine and the development of their viral risk assessment and response plan.
Kevin Carrick from US Pharmacopeia, USA will discuss the 2008 heparin contamination.
Watch and participate in this interactive virtual discussion group on September 14, 2022. There is no cost to register. Registration includes access to the live meeting and presenters’ slides. Registration will close September 13, 2022.