www.uventia.com Open in urlscan Pro
2a02:4a8:ac24:110::10:146  Public Scan

URL: https://www.uventia.com/event/4th-annual-extractables-leachables-summit-2024/
Submission: On February 15 via manual from US — Scanned from DE

Form analysis 4 forms found in the DOM

POST /event/4th-annual-extractables-leachables-summit-2024/#wpcf7-f2928-p6218-o1

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POST /event/4th-annual-extractables-leachables-summit-2024/#wpcf7-f2928-p6218-o2

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      <li><label for="select-432">Where did you heard about this event? <em class="cf7s-reqd">*</em> </label><span class="wpcf7-form-control-wrap" data-name="select-432"><select class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required"
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POST /event/4th-annual-extractables-leachables-summit-2024/#wpcf7-f5740-p6218-o3

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4TH ANNUAL EXTRACTABLES & LEACHABLES SUMMIT 2024

 1. uventia
 2. Events
 3. Pharma
 4. 4th Annual Extractables & Leachables Summit 2024

DISCOUNT 10%
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Event Details
 * 21
   Days
   05
   Hours
   10
   Min
   29
   Sec
 * Start Date
   March 7, 2024 10:00 am
 * End Date
   March 8, 2024 5:30 pm
 * Status
   Upcoming
 * Location
    * Online

 * Price
   €415 - €595

 * Organizer
    * Uventia

 * Category
    * Pharma

 * Email
   register@uventia.com
 * Network
    * 
    * 

 * Time zone
   
   Central European Time

 * Language
   
   English

 * Zoom
   
   video platform

Add to Calendar
 * OVERVIEW
 * SPEAKERS
 * AGENDA

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.

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Fill out the Request Form to receive the Event Brochure
 1. Title * Mr.Ms.Mrs.Dr.
    First Name *
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Speaking Companies



Our Sponsors

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SPEAKER SPONSOR

Previous Events



Expired
[•REC] - €395
3rd Annual Extractables & Leachables Summit 2023
 * Pharma

March 9, 2023
 * Online

Expired
[•REC] - €375
2nd Annual Extractables & Leachables Summit 2022
 * Pharma

March 30, 2022
 * Online


 * ATTENDEES IN 2023
 * ATTENDEES IN 2022

ATTENDEES IN 2023

● 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

ATTENDEES IN 2022

● 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.


REGISTER NOW



Speaker Board

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BECOME A SPEAKER













Become a Speaker of the Event
 1. Title * Mr.Ms.Mrs.Dr.
    First Name *
    Last Name *
    Job title *
    Company *
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    Email *
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    policy.












J. Susanne Becker
Head of Extractables and Leachables Labs
Intertek (Schweiz) AG
 * 

Will Parker
E&L Technology Manager
West Pharmaceutical Services
 * 

Ana Kuschel
Principal Scientific Affairs
West Pharmaceutical Services
Armin Hauk
Principal Scientist
Sartorius Stedim Biotech GmbH
Katherine Lovejoy
Application Chemist
Thermo Fisher Scientific
 * 

Jason Creasey
Managing Director
Maven E&L Ltd
 * 

Divya Regulagedda
Manager (Global SME)
Chemo Group
 * 

Jianwei Li
Principal E&L
Chemical Characterization Solutions LLC
 * 

Candice Johnson
Senior Research Scientist
Instem
 * 

Frank Liu
Director, Safety and Toxicology
Estee Lauder Companies
 * 

Erika Udovic
Senior Principal Scientist
Novartis Pharma AG
 * 

Mourad F. Rahi
Senior Consultant Chemist
Preclintox Services, LLC
 * 

Dujuan Lu
E&L Manager/Global Leader
SGS Health Science
 * 

Charlie Modlin
Application Scientist
Lhasa Limited
 * 

Douglas Kiehl
Research Advisor
Eli Lilly
 * 

Steve Zdravkovic
Research Scientist II
Baxter Healthcare
 * 

Etienne Michel
Global QA for E&L
GSK Vaccines
 * 

Marine Lepoutre
E&L Global SME
GSK Vaccines
 * 

Clemens Guenther
Director, Senior Expert Nonclinical Safety
Bayer AG
 * 


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Summit Agenda

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Fill out the Request Form to receive the Event Brochure
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    policy.









 * March 7
 * March 8

March 7, 2024
10:00 - 10:15
REGISTRATION

March 7, 2024
10:30
Extractables and leachables from single-use systems and their assessment in
advanced therapy medicinal product (ATMP) production

◆  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-GmbH




SARTORIUS STEDIM BIOTECH GMBH, DE

Speakers:
 * Armin Hauk
   Principal Scientist
   Sartorius Stedim Biotech GmbH

March 7, 2024
11:10
Implementation of a non-volatility test before quantitating E&L unknowns with a
charged aerosol detector

◆  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-Scientific




THERMO FISHER SCIENTIFIC, DE

Speakers:
 * Katherine Lovejoy
   Application Chemist
   Thermo Fisher Scientific

March 7, 2024
11:50
Toxicological assessments in E&L

◆  PQRI's recommendations for analytical and safety thresholds.

◆  The QSAR application and qualification standards.

◆  Analyzing toxicological risk and toxicity data.



Bayer




BAYER AG, DE

Speakers:
 * Clemens Guenther
   Director, Senior Expert Nonclinical Safety
   Bayer AG

March 7, 2024
12:20 - 13:20
Lunch Break

March 7, 2024
13:20
[Speaker Sponsor] From Extractables Study to Leachables Study – from screening
methods to validated target methods for Stability Testing in E&L

◆  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.



Intertek




INTERTEK, CH

Speakers:
 * J. Susanne Becker
   Head of Extractables and Leachables Labs
   Intertek (Schweiz) AG

March 7, 2024
14:00
The current state and analytical challenges with the evaluation of E&L in
pharmaceutical and medical device industries

◆  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:
 * Jianwei Li
   Principal E&L
   Chemical Characterization Solutions LLC

March 7, 2024
14:40
Approaches to the use of in silico methods in the toxicological assessment of
extractables and leachables

◆  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.



Instem




INSTEM, USA

Speakers:
 * Candice Johnson
   Senior Research Scientist
   Instem

March 7, 2024
15:20
Sensitization safety assessment of extractables and leachables in pharmaceutical
products

◆  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-Companies




ESTEE LAUDER COMPANIES, USA

Speakers:
 * Frank Liu
   Director, Safety and Toxicology
   Estee Lauder Companies

March 7, 2024
16:00
TBA

◆  



Lhasa-Limited




LHASA LIMITED, UK

Speakers:
 * Charlie Modlin
   Application Scientist
   Lhasa Limited

March 7, 2024
16:50
System suitability and incubation effects on extractables following exhaustive
extraction

◆  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,-LLC




PRECLINTOX SERVICES, LLC, USA

Speakers:
 * Mourad F. Rahi
   Senior Consultant Chemist
   Preclintox Services, LLC

March 7, 2024
16:30 - 16:40
Chairman’s closing remarks and end of day one

March 8, 2024
10:00 - 10:15
REGISTRATION

March 8, 2024
10:30
Cumulative effect vs lego mode: how to simplify extractable approach

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

Speakers:
 * Etienne Michel
   Global QA for E&L
   GSK Vaccines
 * Marine Lepoutre
   E&L Global SME
   GSK Vaccines

March 8, 2024
11:10
Leachable risk assessment approaches: a comparison of USP , biophorum, and other
methods for assessing leachable risk in biopharmaceutical manufacturing systems

◆  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

Speakers:
 * Jason Creasey
   Managing Director
   Maven E&L Ltd

March 8, 2024
11:50
Safety assessment of E&Ls: challenges with different administration routes

◆  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

Speakers:
 * Erika Udovic
   Senior Principal Scientist
   Novartis Pharma AG

March 8, 2024
12:30
E&L testing for medical devices

◆  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

Speakers:
 * Divya Regulagedda
   Manager (Global SME)
   Chemo Group

March 8, 2024
13:00 - 14:00
Lunch Break

March 8, 2024
14:00
Results of the elsie lab practices sub team’s surveys for understanding
intra-lab method/procedure variations for the execution of extractable screening
studies

◆  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

Speakers:
 * Steve Zdravkovic
   Research Scientist II
   Baxter Healthcare

March 8, 2024
14:40
A novel simultaneous uhplc-uv-cad-hrms multi-detector platform for comprehensive
extractables and leachables analysis of pharmaceutical packaging and medical
device materials

◆  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

Speakers:
 * Dujuan Lu
   E&L Manager/Global Leader
   SGS Health Science

March 8, 2024
15:20
Elastomer closures materials (TBC)

◆  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

Speakers:
 * Will Parker
   E&L Technology Manager
   West Pharmaceutical Services
 * Ana Kuschel
   Principal Scientific Affairs
   West Pharmaceutical Services

March 8, 2024
16:10
[Available for Sponsors]

◆  Sponsoring the event is a great way to introduce your brand to an interested
audience.

◆  You can find sponsorship options on the Sponsorship page.

◆  To book and secure a package - please send back a scan copy (or electronic
version with electronic signature) of the registration form with your details
(last page of the agenda). It is also possible to register directly via the
Website.

◆  The moment you book a package your info will be added to the brochure which
is being distributed within our network and through our marketing channels.

◆  To learn more, contact us info@uventia.com

March 8, 2024
16:50
Pharma 4.0/5.0, FDA/FRAME and digital twins: Enabling advanced manufacturing and
digital transformation in pharma through cross-collaborative partnerships

◆  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

Speakers:
 * Douglas Kiehl
   Research Advisor
   Eli Lilly

March 8, 2024
17:20 - 17:30
Chairman’s closing remarks and end of day two


REGISTER NOW



Event Details
 * 21
   Days
   05
   Hours
   10
   Min
   29
   Sec
 * Start Date
   March 7, 2024 10:00 am
 * End Date
   March 8, 2024 5:30 pm
 * Status
   Upcoming
 * Location
    * Online

 * Price
   €415 - €595

 * Organizer
    * Uventia

 * Category
    * Pharma

 * Email
   register@uventia.com
 * Network
    * 
    * 

 * Time zone
   
   Central European Time

 * Language
   
   English

 * Zoom
   
   video platform

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 * Events
 * Pharma

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