3rd Annual Extractables & Leachables Summit 2023 - uventia

3rd Annual Extractables & Leachables Summit 2023

3rd Annual Extractables & Leachables
Event Details

CONFERENCE OVERVIEW

Evaluation of extractables and leachables (E&L) is a crucial step in the plan for product development. The interaction of pharmaceutical products with container closure systems, drug delivery devices and bioprocess manufacturing systems is a major concern for regulatory agencies. So, it is important to thoroughly assess the migration of mobile molecules from the components and substances used in the manufacture and storage of drugs.ade mechanisms for different product types.

Join our event to learn innovative techniques for analyzing and testing for extractables and leachables in biopharmaceutical development. This should help you to significantly lower the risks associated with E&L and assure patient safety and product integrity.

WE WILL TALK ABOUT

  • Extractables and leachables assessments in biologics manufacturing processes.
  • Characterization and cell-growth-inhibiting effect of bDtBPP analogue degradants released by polyolefin bioprocessing materials.
  • Material changes - staying agile when supply chains are fragile.
  • Toxicological assessment in E&L.
  • UPLC/MS and GC/MS method development and validations of extractable and leachable compounds of a parenteral product.
  • The use of computational methods in the assessment of extractables and leachables.
  • Strategies for assigning compound identities and dealing with unknowns in E/L studies.
  • Talk title: how to write a toxicological risk assessment to support extractables and/or leachables: a step-bystep process.
  • USP’s perspective on the development of system suitability standards for the screening analysis of extractables and leachables.
  • Regulatory tools for medical device evaluation: chemical risk calculators (CHRIS).
  • FAQ: frequently asked questions related to rubber extractables.
  • Advancements in E&L assessments – practical guide for the (bio) pharmaceutical manufacturer.
  • E&L strategies for the registration and lifecycle management of inhaled pharmaceutical products in the current and future regulatory landscape.
  • Extractables and leachables potential concerns with high potency APIs.
  • Ensuring patient safety through accurate E&L testing.
  • Analytical considerations in extractables and leachables testing of drug-device combination products.
  • Workflow for identifying and monitoring antioxidant additives in singleuse systems.
  • How to implement USP 665 requirements before 2026.
  • Duration-based non-mutagenic thresholds of toxicological concern (TTC) for parenteral extractables and leachables.
  • Using expert knowledge and machine learning to assess the mutagenicity and sensitisation potential of extractables and leachables.

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] 3rd Annual Extractables & Leachables Summit 2023

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

Speaking Companies
Previous Events

● 3M ● Albhades ● ALK-Abelló S.A. ● Analytical Expertise Center, MoH of Azerbaijan Republic ● Antibiotice SA ● AstraZeneca ● B. Braun Medical Industries Sdn. Bhd ● B. Braun Medical SA ● Bausch Health ● Baxter Healthcare ● Bayer AG ● BD ● Bicycle Therapeutics ● BioConnection BV ● Biogen ● Brainfarma Industria Quimica e Farmacêutica S.A. ● Chorley Consulting Ltd ● CleanControlling Medical GmbH & Co. KG ● CSL Behring ● Datwyler ● Donaldson ● Donaldson BV ● Dr. Anika Schroeter e.U. ● DuPont ● E.L-Xpert Ltd ● Element Material Technology ● ELSIE Consortium ● EQUITOX ● Fastnet Biopharma ● Fischer PreclinTox Consulting ● Fresenius Kabi ● Gateway Analytical ● GBA Pharma GmbH ● GE HealthCare ● Gilead Sciences ● Gilead Sciences, Inc. ● Greg Erexson Toxicology Consulting ● GSK ● ICU Medical ● Incyte ● Instem ● Intertek Schweiz AG ● Johnson & Johnson ● Laboratorios Normon SA ● LACER, S.A.U ● Lhasa Limited ● Lonza ● Lonza Drug Product Services ● Made Consulting Ltd Oy ● Mallinckrodt Pharmaceuticals ● Merck Group ● Merck KGaA ● Neotron Spa ● Octapharma ● Padagis Israel Pharmaceuticals ● Pharmaceutical Firm Darnitsa ● PHOX Consulting e.U. ● Polpharma Biologics S.A. ● PolyCine GmbH ● Promega Corp ● Quinta-Analytica, s.r.o. ● Safetree Consulting e.U. ● Sartorius ● SCC Scientific Consulting GMBH ● SEPTODONT ● SGS Health Science ● Sun Pharmaceutical Industries Ltd. ● Terumo Blood and Cell Technologies ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ireland ● Therapeutic Goods Administration ● Thermo Fisher Scientific ● Tofwerk AG ● U.S. Pharmacopeia ● United States Pharmacopeia ● Universidade de São Paulo ● US Food and Drug Administration ● Waldemar Link ● Westlake ● Wonderboom, Inc. ● WuXi AppTec

● 3M ● Aché ● Adjutant Solutions Group LLC ● AGC Biologics ● Albhades Provence ● ALK-Abelló S.A. ● Aptar Pharma ● AstraZeneca ● Athens Analysis Laboratories ● B.Braun Melsungen AG ● Baxter Healthcare ● Bayer AG ● BBraun Avitum Italy SpA ● Becton Dickinson ● Biogen ● BioNTech ● Boston Scientific ● BSC International Medical Trading ● Carl Zeiss Meditec AG ● Charles River ● Cytiva ● Dalton Chemical Laboratories Inc. ● Deva Holding A.Ş. ● Eli Lilly ● Eli Lilly & Co. ● Gador ● Galapgos NV ● Galderma ● Gilead Sciences ● GlaxoSmithKline Biologicals ● GlaxoSmithKline Biologicals Kft. ● Greiner Bio-One GmbH ● GSK Vaccines ● Hall Analytical ● HORIBA Scientific ● Incyte ● Incyte Biosciences Tech Ops ● Intertek (Schweiz) AG ● L.Molteni & C. dei F.lli Alitti SpA ● LGC Standards ● Lhasa limited ● Lonza ● Medela AG ● Merck KGaA ● Nelson Laboratories ● Niutec AG ● Norbrook Laboratories Ltd ● Norner AS ● Novartis Pharma AG ● Octapharma AB ● Par Pharmaceutical ● Pharma Mar ● Pliva Croatia Ltd. ● PLIVA Hrvatska d.o.o. ● QUINTAANALYTICA s.r.o. ● Regeneron ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi-Aventis ● Sanofi-Aventis R&D ● Sartorius ● Sartorius Stedim Biotech GmbH ● Sumitomo Dainippon Pharma Co., Ltd. ● Takeda Pharmaceutical Co. Ltd. ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals Ireland ● TRIS Pharma ● UCB Biopharma SRL ● Waters Corporation ● Waters GmbH ● West Pharmaceutical Services ● Xellia d.o.o.

● AbbVie, Inc. ● Albhades Provence ● Altran ● AryoGen Pharmed ● AstraZeneca ● B. Braun Medical AG ● Bayer AG ● Bio-Technology General (Israel) Ltd. / Ferring Pharmaceuticals ● Biogen ● Boehringer Ingelheim ● Butterworth Laboratories Ltd ● Carso ● Cenexi ● Chemo SA ● Chiesi Farmaceutici spa ● CMIC Pharma Science Co.,Ltd. ● Constantia Patz Ges.m.b.H. ● ConvaTec ● CSL Behring AG ● ELPEN Pharmaceutical Co. Inc. ● GSK ● GSK Vaccines ● Hall Analytical ● Illumina ● Imperial Brands ● Incyte ● Intertek (Schweiz) AG ● Intervenance NG ● Jagiellońskie Centrum Innowacji ● Laboratorio Reig Jofre, S.A. ● Lonza ● Lonza DPS ● Medtronic LTD. ● Merck Healthcare KGaA ● Merck Serono ● Microvention Inc. ● Minapharm Pharmaceuticals ● National Institute for Bioprocessing Research and Training (NIBRT) ● Nelson Labs Europe ● NNE ● Norner AS ● Novartis ● Octapharma ● Pharma Quality Europe srl ● PHARMA-DATA S.A. ● Polpharma ● ProPharma Group ● Regeneron ● S&C BEST Srl ● SaniSure ● SCIEX ● SGD Pharma ● Solvias AG ● Swissmedic ● Synthon Hispania ● Takeda ● Takeda Pharmaceuticals ● Taro Pharmaceuticals inc. ● Teva Pharmaceuticals ● UAB Teva Baltics ● UCB Biopharma SRL ● Viatris ● Waters Corporation ● Watson-Marlow Fluid Technology Group ● WuXi Biologics ● Xellia Pharmaceuticals

MEDIA PARTNERS

Speaker Board
Nick Morley
Principal Scientist
Element Material Technology
David Saylor
Research Materials Engineer
FDA
Melisa Masuda-Herrera
Senior Associated Scientist
Gilead Sciences Inc.
G. Prabhakar Reddy
Senior Principal Scientist – Team Leader
United States Pharmacopeia (USP)
Weifeng Lin
Staff Scientist
Thermo Fisher Scientific
Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
Tanja Verena Maier
Scientist
Sartorius
Markus Obkircher
Director R&D
Merck KGaA
Graham Wilson
Extractables & Leachables Specialist Consulting Services
E.L-Xpert Ltd
Charlie Modlin
Application Scientist
Lhasa Limited
Tine Hardeman
Manager Material Development
Datwyler
Jianfeng Hong
Sr. Research Scientist
Fresenius Kabi
Glenn J. Myatt
Vice President, Informatics
Instem
Steve Zdravkovic
Research Scientist II
Baxter Healthcare
Etienne Michel
Global QA for E&L
GSK Vaccines
Marine Lepoutre
E&L Global SME
GSK Vaccines
Greg Erexson
Senior Principal Research Toxicologist
Greg Erexson Toxicology Consulting, LLC
Lukas Mogler
Principal Scientist / Sr. Group Lead
Lonza DPS
Alicja Sobańtka
Team Lead Corporate Material Qualification
Octapharma
Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
Andrew Feilden
European E&L Strategic Director
Bicycle Therapeutics

Summit Agenda

◆  EL studies for single use systems used for biologics.

◆  Challenges for biologics manufacturing processes.

◆  Risk based EL assessments.

Lonza Drug Product Services, CH

◆  Finding, Synthesis and full analytical characterization of bDtBPP Analogue Degradants.

◆  Investigation and assessment of the cell-growth-inhibiting effect of two bDtBPP analogue degradants in comparison to bDtBPP (ASTM E3231 – 19).

Sartorius, DE

◆  PQRI's guidance on safety and analytical thresholds.

◆  Qualification criteria and QSAR application.

◆  Examining toxicological risk and toxicity data.

Bayer AG, DE

This presentation describes the design of method development and validation of several representative extractable/leachable compounds in a parenteral product using GC/MS, head space GC/MS and UPLC/MS techniques. The rationale of the selections of the compounds and the analytical method performance requirements are presented. The validated method parameters and validation results are presented: (1) Limit of Quantitation, (2) Accuracy/recovery, (3) Linearity and (4) Standard/sample stability. The validated analytical methods are also successfully used for leachable testing of the parenteral products that have been stored under ICH conditions.

Fresenius Kabi, USA

◆  Outlines the use of in silico approaches supporting the assessment of extractables and leachables.

◆  Describes the prevalence of predicted mutagens and potent sensitizers in large representative databases of extractables and leachables.

◆  Discusses the use of in silico models to assess leachable reactivity with biomolecules.

Instem, USA

◆  Proper use of mass spectral libraries in conjunction with manual interpretation in assigning identities.

◆  Need for the use of, and considerations for, identification confidence levels associated with reported E/L compounds.

◆  Classifying a compound as a non-mutagen/cohort of concern without achieving full structure characterization.

◆  Separating true E/L compounds from various “false positives” that can arise in the data.

Baxter Healthcare, USA

◆  Analytical identification of E&L compounds (tentative, definitive and unknowns).

◆  No toxicity data exists for your E&L compound: What to do?.

◆  The E&L toxicology risk assessment process.

◆  Derivation of maximum daily exposure (MDE) values.

◆  Regulatory guidance as references for PDE values.

◆  Toxicology databases to obtain toxicity data.

◆  Selection of the point of departure to derive the PDE value.

Greg Erexson Toxicology Consulting, LLC AbbVie Retiree, USA

◆  Overview of regulatory tools and their role in marketing submissions to CDRH.

◆  Introduction to CHemical RISk calculators (CHRIS) - a collection web-based tools to facilitate the use of physics-based models in medical device biocompatibility evaluation.

◆  Discussion of CHRIS roadmap – additional tools under development.

US Food and Drug Administration, USA

◆  Answers to the most frequently asked questions on rubber extractables.

◆  Based on case studies, ranging from simple questions to more complex investigations.

◆  Examples concerning elemental impurities, organic extractables, nitrosamines...

Datwyler, BE

◆  Material risk assessment is still key to any E&L assessment.

◆  Use of diffusion modeling can help estimate a more realistic E&L concentration for the acutal use condition.

◆  Insights into the assessment of interactions between E&L and therapeutic proteins.

Octapharma, AT

◆  Why are large molecules of more concern.

◆  Challenges of highly hazardous APIs.

◆  Interaction of biologicals with leachables.

Bicycle Therapeutics, UK

◆  ISO/IEC 17025 requirements, traceability, and uncertainty.

◆  Certification of relevant reference standards.

◆  Intended use of CRMs, applications, and use cases.

◆  Proficiency testing to improve your laboratory performance.

◆  Compound databases for screening.

Merck KGaA, CH

◆  Regulatory & industry guidance to follow for E&L study design of Drug-Device Combination Products.

◆  Difference & Similarity on E&L requirements between pharmaceutical products and medical devices.

◆  (USP <1663> vs. ISO 10993-18).

◆  Case studies on E&L Testing of combination products.

SGS Health Science, USA

◆  A complete workflow based on the accelrated solvent extraction (ASE) technique and LC/HRAM-MS was developed to screen antioxidants and their derivatives in SUS polymeric materials.

◆  ASE enables high throughput, high efficiency, and reproducible extraction of antioxidants from SUS polymeric materials.

◆  Acquisition of the HRAM data on an Orbitrap LC/MS system allowed both targeted screening of known antioxidants, as well as the detection and identification of unknown or unexpected additives, including derivatives or degradants.

Thermo Fisher Scientific, USA

The goal will be to present a lifecycle approach of our existing park of single-use, based on leachable risk, to ensure a compliance for the effectivity date of the USP in 2026.

 

◆  Management of existing items, lifecycle and retrospective approach.

◆  Management of new items created between 2021 and 2026

◆  Ensure full compliance for items after 2026.

◆  Quid of Chinese pharmacopea?

GSK, BE

◆  The ELSIE consortium derived duration-based, non-mutagenic TTCs for parenteral extractables and leachables substances..

◆  This presentation will provide a brief background on the risk management framework developed by ELSIE and previous applications of the TTC concept.

◆  Additionally, this presentation will focus on the process for deriving the TTCs, which includes an overview of the ELSIE database, the data evaluated to determine the parenteral point of departure (PPOD), and application of adjustment factors.

Gilead Sciences, Inc., USA

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