Conference presentation on strategies for control of extractables & leachables
During the 3rd Annual Extractables & Leachables, our expert, Dr Tino Otte will present a Keynote Address "Screening and Control of Extractables & Leachables – An Analytical Approach"
If you would like a copy of the presentation, please contact us now:
Due to the increasing bio-pharma growth more and more polymer materials are in contact with pharmaceutical formulations during production and final storage. Polymers, but also related materials like printing or adhesives, often contain a high number of additives and other functional small molecules to tailor and retain the product properties. Unfortunately, these small molecules are easily leached out by pharmaceutical formulations.
Therefore, residues of leachable compounds and their degradation products are frequently observed as contaminations in API and final formulations. Some leachables are known to be mutagenic and many of them pose at least a certain reactivity. For this reason, leachables could cause adverse effects on the human body even if only present at trace level concentration.
The detection, quantitation, and evaluation of such molecules is important but could be very challenging since matrix effects often discriminate the compounds of interest. During the 3rd Annual Extractables & Leachables Conference, we present on an appropriate stepwise study design to help to overcome such issues. This study design should yield data which will allow estimation of the toxicological risk for the patient. In our presentation we focus on compendial guidelines for E&L studies, highlight the analytical challenges and propose possible solutions to these challenges:
- Sources for known and unknown leachables
- General screening - choosing the right techniques
- Reasonable analytical control strategy
- Structure elucidation and quantification of leachables in complex matrices
- Validation and routine monitoring
Where: Berlin, Germany
When: Day 1, Session 1: E & L Practices, December 1st
Meet our Expert
Dr. Tino Otte is the Head of the Sales and Consulting Department at Intertek in Switzerland. He joined the company in 2016. Tino is an expert in extractables & leachables studies, impurity characterization and analytical method development. He has more than 13 years of experience in pharmaceutical analysis and polymer characterization. Tino is a chemist by training with a PhD in Analytical Polymer Chemistry from the Technical University of Darmstadt, where he graduated in 2010. Prior to joining Intertek, he worked at different service providers for pharmaceutical industry and analytical Instrument manufacturers in Switzerland and Germany.
If you’d like to meet with our expert during the conference, contact us now:
Intertek’s decades of experience and industry expertise in providing in-depth identification and analysis of extractables and leachables provides solutions for a wide variety of products, including pharmaceutical finished products, medical devices, and pharmaceutical consumer products. Our GMP-compliant laboratories in Europe and US provide convenience for customers worldwide to meet needs for extractable and leachable studies. Our Centre of Excellence for Extractables and Leachables in Europe is our laboratory in Reinach, Switzerland which has over 20 years of experience in E&L study design and delivery.
More about the Event
The BCF 3RD Annual Extractables and Leachables Hybrid Conference will take place in person Dec 1-2 in Berlin, Germany and online on the Bigmarker Platform. The main goal of the event is to bring professionals of the industry to discuss the latest trends and innovations in Toxicology. The agenda will cover these challenges and more:
- E & L Practices: Chemical Characterization; Toxicological Risk Assessment; Material Characterization
- E & L Compounds Analysis: Screening Methods; High Resolution Mass Spectrometry Technology Usage; Managing Unknown Compounds
- Regulatory Considerations: ISO 10993-18 Updates; FDA Guidance; ISO 10993-17:2022
- Medical Device Evaluation: TTC Application; AET Establishing Considerations; Challenges With E & L
- Advanced E & L Testing Techniques: Small Molecule Identification Methods Analytical Workflow for E & L Testing; Multi-detector Strategy for Reducing Response Factor Variation
- White Paper Download | Extractables and Leachables Strategies for Prefilled Syringes
- Whitepaper Download | Extractables and Leachables Strategies for Pharmaceutical Production Tubing