Cambridge Healthtech Institute recently spoke with Dr. Kim Li of Amgen about challenges in managing Extractables & Leachables and her upcoming keynote presentation “Extractables & Leachables Safety Information Exchange (ELSIE) Consortium – Update” at the 5th Annual Extractables and Leachables conference, taking place January 10-11, 2017 as part of the 16th Annual PepTalk event which runs from January 9- 13, 2017 in San Diego, CA.

Q Can you tell us about yourself and your work?

I am a board certified toxicologist and have broad experience in safety assessments in both R&D and Operations environment. My industry experience include biopharmaceutical products, agrochemicals, consumer healthcare products and medical devices. In my current role at Amgen, I am the lead toxicologist on extractables and leachables (E&L) programs for container closure systems, drug delivery devices and single use technologies. I serve on the Extractables & Leachables Safety Information Exchange (ELSIE) consortium in various capacities: Vice-chair of the ELSIE Board of Directors, Chair of the Executive Committee and prior to that, as co-lead for the Safety Information Working Group. I am also active on ISO 10993 Biological Evaluation working groups to advance our knowledge base around material characterization and toxicology assessments for medical devices.

Q Why did you choose to tackle this topic?

The ELSIE consortium, consisting of members from the pharmaceutical, biotechnology and medical device companies, advances the knowledge of chemical and toxicology assessment of E&L through scientific knowledge sharing and regulatory outreach. The 2017 PepTalk conference is timely for us to share updates from our consortium activities.

Q What are the major challenges that the Extractable and Leachable field is facing?

I believe the most significant challenges that the scientists face in the E&L field are the widespread use of complex polymeric materials and the testing required for their intended applications. The testing may include material characterization (physical, chemical, functional performance) and safety evaluation (biocompatibility testing, toxicology assessments). The testing standards (e.g. ASTM, USP, ISO), developed more than a decade ago, are in need of updates to reflect the most current technologies and best practices. On the bright side, these significant challenges have created opportunities to advance the knowledge base around the chemistry and toxicology of E&L impurities as they apply to the manufacturing environment and ultimately the quality and safety of the medical devices and combination drug products.

Q Where is the Extractable and Leachable field headed in coming years and what’s revolutionizing Extractable and Leachable research?

The field is rapidly changing and we need to adapt to the changes with new tools. First, the universe of extractables arising from contact materials is rapidly expanding into an unwieldly galaxy. The rapid advances in trace analysis and structural elucidation in the chemical space continue to challenge us to examine our risk assessment toolbox. Second, the study of leachables in final drug products can be hindered by assay interference. This is particularly true of biotechnology products for trace levels of leachables in a protein formulation matrix. We need new tools to examine the potential interaction of E&L with the protein formulation matrix. Third, the proliferation of single-use technologies (SUT) has raised regulatory concern and requires a systematic approach to evaluate upstream raw materials through the finished drug product under recommended storage conditions. While there are a myriad of other challenges, it is the concerted efforts by raw material suppliers, the pharmaceutical manufacturers and the regulators to share knowledge and deliver quality and safe products to patients. It is the coming together of these efforts that will revolutionize this field of research.

TO LEARN MORE ABOUT HIS PRESENTATION AND PEPTALK, VISIT: CHI-PepTalk.com/Extractables-Leachables/