4th Annual Extractables & Leachables Summit 2024

The goal will be to present how to manage the cumulative effect and to explain which simplifications can be implemented for extractable studies and patient exposure scenario:

◆  Why extractable studies are not always representatives?

◆  How to deal with cumulative effect described in regulations?

◆  The concept of Lego approach to simplify cumulative evaluation?

◆  How to use of digital tool to support approach and simplify patient exposure scenario and toxicological evaluation?

GSK

GSK Vaccines, BE

◆  There is no agreed format for leachable risk assessment.

◆  Both USP and Biophorum have published guidance.

◆  Presented is an alternative approach that might be considered, covering both severity and probability of leachable risk.

Maven-E&L-Ltd

Maven E&L Ltd, UK

◆  Introduction to general safety and regulatory considerations for extractables/ leachables (E&Ls) in pharmaceutical products.

◆  Considerations for ocular administration routes.

◆  Assessment strategies for intrathecal (IT) route of administration.

Novartis

Novartis Pharma AG, CH

◆  Chemical characterisation of medical device materials and ISO 10993-18.

◆  Evaluation of biocompatibility and toxicological risk.

◆  The verification of analytical methods.

Chemo

Chemo Group, ES

◆  Annecdotely, it’s been stated that extractable screening data obtained between laboratories will be unaligned to at least some extent in the qualitative and/or quantitative profiles reported, which has been hypothesized to be attributable to differences in the methods and procedures used.

◆  To that end, ELSIE has surveyed a large number of CRO and pharmaceutical (sponsor) companies with the goal of better understanding variations in methods and lab practices used between labs with the goal of understanding the extent of such variation that currently exists in the E/L field.

◆  This presentation will discuss the data obtained from these surveys, highlighting areas of alignment, or lack thereof, for key method/procedural aspects including surrogate standard selection, uncertainty factor determination and usage, system suitability parameters, and relevant methodology variables.

Baxter-Healthcare

ELSIE

Baxter Healthcare, USA

◆  We will demonstrate the combination of the three detection techniques in one system to allow the concurrent measurement of UV absorption, Charged Aerosol Detection (CAD) signal and high resolution-accurate mass (HRAM) mass spectra from one injection.

◆  The inclusion of CAD detection provides complementary information to UV and HRMS, enabling more reliable semi-quantitation of non-chromophoric and non-volatile compounds.

◆  Several case studies will be shown with the application of this multi-detector approach in extractable studies of pharmaceutical packaging and medical device components. 

SGS-Health-Science

SGS Health Science, USA

◆  Composition of elastomers used for pharmaceutical applications.

◆  Material composition and extractables.

◆  How to minimize extractables/leachables from elastomeric closures.

WestPharma

West Pharmaceutical Services, USA, DE

◆  Agilent comprehensive portfolio to mitigate risk of E&L.

◆  Analytical Workflow strategies & Solution.

• Scouting approach using modern molecular spectroscopy solution.
• Identification & quantitation of E&L for volatile/ Semi-volatile Impurities using GCMS solution.
• Streamlining Elemental Impurities, Extractables and Leachable Workflows Flow with Agilent Time Trap Analytical Solution.

Agilent

Agilent Technologies Deutschland GmbH, DE

◆  What are the current drivers for Digital Transformation in Pharma?

◆  How is Pharma 4.0/5.0 defining the disruptive and transformative roadmap for more expedient operations, product development, advanced manufacturing, supply chain and lifecycle management?

◆  How are digital twins and cross-collaborative partnerships primary enablers for advanced manufacturing and digital transformation in pharma?

EliLilly

Eli Lilly, USA