ELSIE Consortium

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).

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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

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 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

Baxter
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American Regent
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Amgen
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AbbVie
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AstraZeneca
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Bayer
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BBraun
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Boehringer Ingelheim
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Biogen
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Bristol Myers Squibb
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Bracco
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Eli Lilly
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EMD Serono
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EVER Pharma
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Genentech/Roche
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Gilead Sciences
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GSK
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Johnson & Johnson
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LFB
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Merck
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Regeneron
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Ultragenyx
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Verona Pharma
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Viatris
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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

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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.

Request for Information (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.

Request for Quote (RFQ) Announcement -
Extractables Study for Elastomer Vial Stoppers (Coated and Uncoated)

ELSIE is seeking quotes form laboratories interested in conducting an ELSIE-sponsored extractables study for elastomer vial stoppers (coated and uncoated). Please download the Request for Quote for more project details. 

RFQ Issued: July 8, 2025
RFQ Responses Due to ELSIE: July 25, 2025

For more information on membership, please click here.

Contact Us

For more information on ELSIE and membership inquiries, please contact the ELSIE Secretariat.

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