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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.