4th Annual Extractables & Leachables Summit 2024 - uventia
0
0
0

4th Annual Extractables & Leachables Summit 2024

4th Annual Extractables & Leachables
REQUEST BROCHURE
BUY RECORDINGS
Event Details
Add to Calendar

Conference Overview

One of the most important phases of the biopharmaceutical development process is the evaluation of extractables and leachables. Regulatory bodies are particularly concerned about the interactions of pharmaceutical products with container closure systems, drug delivery devices, and bioprocess manufacturing systems. Therefore, it is crucial to carefully evaluate the migration of mobile molecules from the materials and components used in the production and storage of pharmaceuticals.

We host a virtual conference where scientists, toxicologists, and E&L managers may exchange ideas about the most recent analytical approaches, regulatory updates, risk-based E&L programs, chemical characterization, and toxicological risk assessment. We also discuss analytical and safety thresholds, medical device materials, ISO 10993-18, and customized systems for various product kinds.

Come to our event and discover the latest approaches for extractables and leachables analysis and testing. This should help you greatly reduce the risks connected with E&L while also ensuring patient safety and product integrity.

WE WILL TALK ABOUT

  • Updated regulatory guidelines for E&L testing.
  • Implementation of a non-volatility test before quantitating E&L unknowns with a charged aerosol detector.
  • Toxicological assessments in E&L.
  • The current state and analytical challenges with the evaluation of E&L in pharmaceutical and medical device industries.
  • Approaches to the use of in silico methods in the toxicological assessment of extractables and leachables.
  • Sensitization safety assessment of extractables and leachables in pharmaceutical products.
  • Leachable risk assessment approaches: a comparison of USP <665>, biophorum, and other methods for assessing leachable risk in biopharmaceutical manufacturing systems.
  • Safety assessment of E&Ls: challenges with different administration routes.
  • E&L testing for medical devices.
  • Results of the elsie lab practices sub team’s surveys for understanding intra-lab method/procedure variations for the execution of extractable screening studies.
  • A novel simultaneous UHPLC-UV-CAD-HRMS multi-detector platform for comprehensive extractables and leachables analysis of pharmaceutical packaging and medical device materials.
  • Elastomer closures materials (TBC).
  • Leachable study of a parenteral vial products with complex and challenging formulations.

WHO IS IT FOR?

CxO, VPs, Directors, Heads, Managers of

  • Extractables and Leachables/ E&L
  • Analytical Chemistry/ Analytical Development/Analytical Science
  • Product Characterisation/ Risk Assessment
  • Drug Development/ Drug Substance
  • Drug Safety/ Compound Safety/ Toxicology
  • Device Development/ Device Engineering/Container Development
  • Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP)
  • Manufacturing Science & Technology/ Single Use Systems
  • Bioprocessing/ Bioproduction
  • Regulatory Affairs & Compliance
  • Materials Science/ Materials Selection/ Biocompatibility
  • Packaging & Labelling
  • LC-MS/ Mass Spectrometry

Agenda 4th Annual Extractables & Leachables Summit 2024

Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session.

REQUEST BROCHURE
Speaking Companies

Our Sponsors
BECOME A SPONSOR
Previous Events
3rd Annual Extractables & Leachables
Expired
[•REC] - €345
3rd Annual Extractables & Leachables Summit 2023
March 9, 2023
2nd Annual Extractables Leachables Summit
Expired
[•REC] - €295
2nd Annual Extractables & Leachables Summit 2022
March 30, 2022
BUY RECORDINGS

Speaker Board
BECOME A SPEAKER
Tobias Weimer
Tobias Weimer
Product Specialist LC-MS
Agilent Technologies Deutschland GmbH
J. Susanne Becker
J. Susanne Becker
Head of Extractables and Leachables Labs
Intertek (Schweiz) AG
Will Parker
Will Parker
E&L Technology Manager
West Pharmaceutical Services
Ana Kuschel
Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Armin Hauk
Armin Hauk
Principal Scientist
Sartorius Stedim Biotech GmbH
Katherine Lovejoy
Katherine Lovejoy
Application Chemist
Thermo Fisher Scientific
Jason Creasey
Jason Creasey
Managing Director
Maven E&L Ltd
Divya Regulagedda
Divya Regulagedda
Manager (Global SME)
Chemo Group
Jianwei Li
Jianwei Li
Principal E&L
Chemical Characterization Solutions LLC
Candice Johnson
Candice Johnson
Senior Research Scientist
Instem
Frank Liu
Frank Liu
Director, Safety and Toxicology
Estee Lauder Companies
Erika Udovic
Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
Mourad F. Rahi
Mourad F. Rahi
Senior Consultant Chemist
Preclintox Services, LLC
Dujuan Lu
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Charlie Modlin
Charlie Modlin
Application Scientist
Lhasa Limited
Douglas Kiehl
Douglas Kiehl
Research Advisor
Eli Lilly
Steve Zdravkovic
Steve Zdravkovic
Research Scientist II
Baxter Healthcare
Etienne Michel
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
Marine Lepoutre
E&L Global SME
GSK Vaccines
Clemens Guenther
Clemens Guenther
Former Senior Expert Nonclinical Safety at Bayer AG
Independent Lecturer
BUY RECORDINGS

Summit Agenda
REQUEST BROCHURE

◆  E&L safety assessment in cell and gene therapies (CGT) is challenging.

◆  While suitable extractables data are available, exposure estimations to patients and the ex vivo manipulated biological material need to be improved by exposure modelling.

◆  Additionally, data for toxicological relevant end points for the ex vivo manipulated cells are required.

◆  It will be shown that morphological profiling with a cell painting assays (CPA) using human cells allows to identify potential detrimental effects relevant for E&L safety assessments.

Sartorius-Stedim-Biotech-GmbHSartorius-Stedim-Biotech-GmbH

Sartorius Stedim Biotech GmbH, DE
Speakers:

◆  HPLC with 3 orthogonal detectors allows quantitation of unknowns by charged aerosol detectorand identification by easy-to-use low resolution MS

◆  Classification of unknowns as non-volatile or semi-volatile in the CAD reduces the uncertainty factor and improves quantification by surrogate standard.

◆  When using an inverse gradient, improved mixing with an inline capillary mixer after the merge point of the analytical and inverse gradients reduces inter-compound %RSD

Thermo-Fisher-ScientificThermo-Fisher-Scientific

Thermo Fisher Scientific, DE
Speakers:

◆  PQRI's recommendations for analytical and safety thresholds.

◆  The QSAR application and qualification standards.

◆  Analyzing toxicological risk and toxicity data.

BayerBayer

Bayer AG, DE
Speakers:

◆  Set of Extractables Study under realistic worst-case conditions.

◆  Leachables Simulation Study using drug substance/product solution.

◆  Selections of target compounds, method development and validation according to ICH.

◆  Case studies showing problems and possible solutions.

IntertekIntertek

Intertek, CH
Speakers:

◆  The safety and analytical science expectations of E&L from the perspective of a quantitative “global” space of extractables and leachables in volatility, hydrophobicity, and molecular weight.

◆  A critical review of the current state of analytical testing strategies, including uncertainty on E&L testing.

◆  A critical overview of the major analytical challenges in solvent choice, sample treatment, mass balance, method sensitivity, response factor, accuracy of quantitation and identification, etc, with specific examples.

◆  Tips for choosing an analytical partner.

Chemical Characterization Solutions, LLC, USA
Speakers:

◆  Discusses various contexts in which in silico methods are applied in E&L assessments.

◆  Defines the fitness-for-purpose of in silico models in these contexts.

◆  Demonstrates how in silico profiling could be used to support read-across assessments.

InstemInstem

Instem, USA
Speakers:

◆  Sensitization potential of extractables and leachables: a challenge.

◆  Sensitization safety assessment proposal for extractables and leachables.

◆  A hypothetical case study: the application of the proposal.

Estee-Lauder-CompaniesEstee-Lauder-Companies

Estee Lauder Companies, USA
Speakers:

◆  Introduction to the assessment of E&Ls, particularly through an in silico lens.

◆  How in silico statistical models, expert-knowledge based models, and combined approaches can aid in E&L assessments.

◆  How Lhasa’s in silico solutions make use of combined model approaches to effectively predict hazard and potency of E&Ls.

◆  A worked case study demonstrating the implementation and efficacy of in silico approaches to estimate hazard and potency for E&Ls.

◆  The future of Lhasa’s solutions in the E&L space.

Lhasa-LimitedLhasa-Limited

Lhasa Limited, USA
Speakers:

◆  The shortfalls of system suitability for determination of limit of detection as routinely performed for chemical characterization of solvent extracts of medical devices.

◆  The results and impact of a limited laboratory investigation on the effect of incubation on spiking selected standards commonly used for identification and quantification of extractables.

◆  Biocompatibility testing failure and identification of root cause.

◆  Recommendations to improve extraction and identification of reactive/toxic substances.

Preclintox-Services,-LLCPreclintox-Services,-LLC

Preclintox Services, LLC, USA
Speakers:

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?

GSKGSK

GSK Vaccines, BE
Speakers:

◆  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-LtdMaven-E&L-Ltd

Maven E&L Ltd, UK
Speakers:

◆  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.

NovartisNovartis

Novartis Pharma AG, CH
Speakers:

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

◆  Evaluation of biocompatibility and toxicological risk.

◆  The verification of analytical methods.

ChemoChemo

Chemo Group, ES
Speakers:

◆  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-HealthcareBaxter-Healthcare
ELSIEELSIE

Baxter Healthcare, USA
Speakers:

◆  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-ScienceSGS-Health-Science

SGS Health Science, USA
Speakers:

◆  Composition of elastomers used for pharmaceutical applications.

◆  Material composition and extractables.

◆  How to minimize extractables/leachables from elastomeric closures.

WestPharmaWestPharma

West Pharmaceutical Services, USA, DE
Speakers:

◆  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.

AgilentAgilent

Agilent Technologies Deutschland GmbH, DE
Speakers:

◆  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?

EliLillyEliLilly

Eli Lilly, USA
Speakers:
BUY RECORDINGS

Registration Tickets
2 Days Recording
€375

Recording of 2 days event sessions [18 video sessions].

Digital certificate of attendance.

List of participants.

PDF presentations.

To purchase the summit materials, complete the registration form. After submission, you will receive confirmation and invoice. The package covers access to all material in the proceedings including keynotes, invited presentations and papers, posters, and delegate list with contacts as well as video recordings of speakers' speeches [18 video sessions].

If you need more information, please contact us at info@uventia.com

BUY RECORDINGS

Event Details
Add to Calendar
Sponsors
Event Tags
Share This Event
Related Events
You might also love these events.
DISCOUNT 10%
Visual-Inspection
Visual Inspection in Parenterals Summit 2025
June 5, 2025
11:50 am
Stay updated on industry trends, improve product quality and ensure safety in parenteral drug manufacturing.
Upcoming
€415 - €595
2nd Annual Cleaning Validation Summit 2025
2nd Annual Cleaning Validation Summit 2025
October 1, 2025
11:50 am
A premier two-day event dedicated to best practices, regulatory expectations and emerging trends in pharmaceutical cleaning validation.
Upcoming
€415 - €595
Combination Products Summit
Combination Products Integrated Development Summit 2026
April 2, 2026
10:00 am
What are critical considerations on drug-device integrated development and how to choose the right regulatory and clinical strategy?
Upcoming

This site uses cookies. Find out more about cookies and how you can refuse them.

I Accept