Welcome to ELSIE
The Extractables and Leachables Safety Information Exchange (ELSIE)
Consortium of pharmaceutical, biotechnology, and medical device companies that formed in 2007 to serve as leading industry voice and scientific resource on extractables and leachables (E&L).
ELSIE Database
Each ELSIE Safety Report contains information on
Chemical information
Acute to Chronic Toxicity
Mutagenicity/ Carcinogenicity
Reproductive/ Developmental Toxicity
Absorption, Distribution, Metabolism, and Excretion (ADME)
ELSIE Members
- AbbVie
- Alcon
- American Regent
- Amgen
- AstraZeneca
- Baxter
- Bayer
- BBraun
- Biogen
- Boehringer Ingelheim
- Bracco
- Bristol Myers Squibb
- Elanco
- Eli Lilly
- EMD Serono
- EVER Pharma
- Fresenius Kabi
- GE HealthCare
- Genentech/Roche
- Gilead Sciences
- GSK
- Hikma
- Johnson & Johnson
- LEO Pharma
- LFB
- Merck
- Novartis
- Novo Nordisk
- Octapharma
- Organon
- Pfizer
- Regeneron
- Sandoz
- Sanofi
- Takeda
- Teva
- UCB
- Ultragenyx
- Vantive
- Viatris
Baxter American Regent Amgen AbbVie AstraZeneca Bayer BBraun Boehringer Ingelheim Biogen Bracco Bristol Myers Squibb Eli Lilly EMD Serono EVER Pharma Genentech/Roche Gilead Sciences GSK Johnson & Johnson LFB Merck Regeneron Ultragenyx Verona Pharma Viatris
American Regent
Amgen
AbbVie
AstraZeneca
Baxter
Bayer
BBraun
Biogen
Boehringer Ingelheim
Bristol Myers Squibb
Bracco
Eli Lilly
EMD Serono
EVER Pharma
Genentech/Roche
Gilead Sciences
GSK
Johnson & Johnson
LFB
Merck
Regeneron
Ultragenyx
Verona Pharma
Viatris
about ELSIE
The ELSIE Consortium
Collects, reviews, and compiles toxicological data on leachables and extractables in an information-rich database, enabling rigorous assessments.
Advances understanding of the impact of extractables and leachables on product quality and process performance.
Provides opportunities to share and leverage experiences, insights, and practices with respect to the potential safety impact of drug product packaging, delivery and manufacturing systems.
Awards Winning
Our Equipments
Field Expertise
Industry Expertise
American Regent
Amgen
AbbVie
AstraZeneca
Baxter
BBraun
Novartis
Biogen
Boehringer Ingelheim
Bristol Myers Squibb
Bracco
Eli Lilly
EVER Pharma
Genentech/Roche
Gilead Sciences
GSK
Johnson & Johnson
LFB
Merck
Bayer
Regeneron
Ultragenyx
Verona Pharma
Viatris
EMD Serono
our locations
Our Company Spread All Over The World
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RFI Announcement -
Supply of Test Mixes for Interlaboratory Study
The ELSIE Consortium is requesting information from laboratories related to the supply of test mixes for an interlaboratory study under the Product Quality Research Institute (PQRI). PQRI has identified a common need to obtain a supply of reference standards mixes to support a planned inter-laboratory study. The study’s primary aim is to explore variation in analyte response and associated response factor / relative response factor for constituents within the supplied reference standard mixes to be supplied to each of the laboratories and used in a variety of deployed/ analytical extractable methodologies.
Please click here to view the RFI for more project details.
RFI responses are due to ELSIE by July 17, 2025.
Core Objectives of ELSIE
- Advances principles of Quality by Design by enhancing the prospects for identifying potential safety issues at the initial stages of the development processes.
Supports member companies’ regulatory filings.
Reduces duplication of effort and minimize testing.
- Decreases the risk of substantial, unanticipated delays and associated costs
For more information on membership, please click here.
Contact Us
For more information on ELSIE and membership inquiries, please contact the ELSIE Secretariat.
Testimonial
Our Happy Customers
Biology Student
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Chemistry Student
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Pharmacy Students
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Physics student
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Pharmacist Student
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