Global Communications

January 12, 2015

Diane Paskiet to Present at Peptalk 2015 January 22 2015

Diane Paskiet, Ph.D., Director of Scientific Affairs, will present “Biopharmaceutical Quality: Factoring Extractables into the Risk Equation” at Cambridge Health Insitute’s 14th Annual PepTalk 2015 conference on January 22-23, in San Diego, CA.  The program, which was co-developed by Thomas Egert, Research Scientist, Boehringer Ingelheim GmbH & Co. KG, will focus on risks to quality posed by materials that contact biologics during manufacturing, storage and those associated with the final packaging configurations can pose risks to quality.

The risk of substances leaching into drug products should be realized. This case study will illustrate relationships between the chemistry of a rubber material and mass transport properties via modeling to enable identification and mitigation of hazards. This knowledge can feed into design of relevant studies to reduce the uncertainty of leachables and contribute to justifications for material selection.

Diane and  Jeffrey Carter, Ph.D., Strategic Projects Leader, GE Healthcare will conduct a short course on January 18, prior to the PepTalk conference, entitled, “Materials in Contact with Biologics: Understanding Risk to Quality and Safety.”

This in-depth course reviews the regulatory requirements, types of materials used and material chemistry, and then examines the strategies for prediction and risk assessment of potential threats to quality and safety of biologics drug products. The course reviews development of a successful analytical strategy for single-use components, container closure components and risk posed by leachables.