Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study will illustrate considerations when conducting a chemical safety assessment, the pitfalls of having unknown chemicals in your chemistry reports, options for mitigating potential risks, and the importance of using toxicologists skilled in these assessments.

Key Lessons Learned:
•    Not all chemicals are equal when it comes to safety risks.
•    Unknown chemicals can cause unnecessary challenges in the safety assessment.
•    Safety assessments should be conducted by qualified professionals.

About the presenter

Dr. Sherry Parker, Senior Director, Regulatory Toxicology and Technical Services, WuXi AppTec
Dr. Sherry Parker, Senior Director, Regulatory Toxicology and Technical Services, WuXi AppTec Image

Dr. Parker has over 20 years of toxicology and medical device experience, and is an expert in analytical, pharmacological, and toxicological evaluations of medical devices and combination products. After receiving her Ph.D. in Molecular and Cellular Pharmacology from the University of Miami, Dr. Parker worked as a toxicologist for the EPA, RTI International, OrbusNeich, and Fresenius Medical Care. In her current position at WuXi AppTec, Dr. Parker provides manufacturers with guidance on global regulatory and technical requirements and testing program design.

In May 2019, Dr. Parker was appointed to a three-year term as co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) Biological Evaluation Committee. In addition, she is currently an internationally recognized ISO expert of TC 194, the technical committee for ISO 10993, and is the President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology.