Extractables and Leachables USA sponsors and exhibitors are leaders in the field who present innovative products and services to an audience of industry professionals and decision makers.
At every stage—disease research, drug discovery/development, quality control, manufacturing—you need the right answers to make the best business decisions for your lab. Speed to decision is critical in any business. All pharmaceuticals must undergo rigorous testing to ensure that they are safe and effective, and products derived from biotechnology require even more sophisticated analytical procedures. Agilent can help meet your needs with high throughput automated systems for compound identification in early discovery and with sophisticated, highly sensitive analytical systems that can provide quick answers to routine questions—for both expert users and trained technicians.
Learn more https://www.agilent.com/en/solutions
The U.S. Food and Drug Administration and European Medicines Evaluation Agency (EMEA) have expressed concerns over potential toxicity and efficacy effects of chemicals released into drug products through exposure to components used in manufacturing and packaging. These chemicals are referred to as Extractables and Leachables (E&L). Accurate and definitive E&L studies should be performed in compliance with USP, ICH, PQRI, and ISO 10993. All E&L studies by Daicel Pharma Services are conducted in their US-FDA audited analytical facility and fully support regulatory compliance. Daicel Pharma Services offers GMP Analytical Services with comprehensive Extractable and Leachables Studies and GMP Stability Studies. Daicel’s Extractable and Leachables studies test a large number of packing materials, manufacturing systems, and drug products, as well as offer Glass Delamination studies to meet the demanding testing specifications of regulatory authorities. Learn more at www.daicelpharmaservices.com
Performing an E&L study is an important part of verifying the safety of a medical, pharmaceutical or packaging product.
Design of an E&L study requires an understanding of the materials used in the construct of the product and the expected use conditions. E&L studies are best conducted using an analytical strategy which is formed by expectations of potential extractables, and which has sufficient breadth for discovery of unexpected components. The laboratory which conducts the study must have sufficient expertise in unknown identification to properly leverage information from multiple techniques, databases and control experiments to allow for positive unknown identification. They must also have the breadth of instrumentation which allows for analysis of a wide range of potential analytes. Finally, they must also be experts at analytical method development utilizing this knowledge to develop quantitative methods for the components identified.
Jordi Labs specializes in the analysis of plastics and has the experience and knowledge to make your E&L study a success. Jordi partners with our customers to develop and execute E&L studies empowered by over 30 years of analytical experience and state of the art instrumentation.
Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 700 laboratory tests and employing more than 700 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.
Companies choose Nelson Laboratories for our:
See how we can help you mitigate risk, be first to market, and succeed with your customers.
Primera Analytical Solutions is a cGMP and GLP contract analytical laboratory in great standing with the FDA. At Primera, quality and client satisfaction are our primary objectives. We strive to excel at a broad number of services such as Method Development and Validation, Impurity Studies to include Genotoxic Impurities (LCMSMS, GCMS, ICPMS), Extractables & Leachables, Stability and Photostability Studies, Dissolution Studies, Abuse-Deterrent Studies, Product Release Testing, Method Transfers, Inhalation Products, and Raw Material Testing. In addition, our scope of services extends to Bioanalytical and Biopharmaceutical Testing.
Our Bioanalytical Group is highly experienced in PK/PD, Metabolite Characterization, Bioavailability and Bioequivalence Studies. Our Biopharmaceutical Group is adept at Bioassay Method Development and Validation, Impurities by ELISA, Anti-Drug Antibody Assays (ADA), peptide mapping and so much more. Our expert team strives to provide you with both timely reports and a level of service unsurpassed in our industry.