US FDA on issues frequently observed in analytical evaluation of leachables and more

Andrey Sarafanov, Chemist - Principal Investigator Center for Biologics Evaluation and Research (CBER) at the US FDA, is set to present at Extractables & Leachables Europe 2018 later this year, so we sat down with him to get a sneak peek of his presentation, his insights on the future of the industry and more.

Q1. Your presentation will provide a review experience of 'Issues frequently observed in analytical evaluation of leachables in drug products', could you give us a preview of what this will entail?

Presently, there are no US regulations (CFR or FDA Guidance for Industry) specific to analytical assessment of E&L in drug products. Therefore, some issues found upon review of new drug applications (NDAs) or supplements for approved NDAs are resolved on a case-by-case basis. Sometimes, it results in a series of communications and may still not address the issue by the end of the review period. This puts unnecessary burden on both review processes and the company's efforts. Avoiding such problems can be achieved with clear understanding of the appropriate procedures, and ideally, description in a guidance for E&L assessment.

Q2. What do you hope your presentation will provide the delegates with?

I will describe the typical problems I often see upon review of data for analytical evaluation of E&L. This could be helpful for the industry to ensure appropriate evaluation of those in respective manufacturing processes.

Q3. Where do you foresee the industry headed in the next 5 years and why?

I believe better harmonisation in the analytical evaluation of E&L will be achieved, and respective regulatory guidance(s) will be developed.

Q4. What are you most looking forward to at E&L Europe 2018?

To get an expert opinion from the scientists on the topics I am going to discuss.


Andrey will be speaking as part of the Case Studies and Analytical Challenges session this November. Just some of the key points that he will discuss as part of his presentation include:

  • Analytical recovery of certain compounds being underestimated
  • Underestimation of respective risk for patients
  • Possible approaches to avoid the above

Other speakers in the session include Mylan, GlaxoSmithKline, Teva Pharmaceuticals, Smithers Rapra, Abbott and more so it really is a must-attend for anyone working with E&Ls. 

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