Extractables & Leachables Testing

Element has one of the largest and most experienced extractables and leachables (E&L) practices in the world.

We deliver tailored E&L studies of pharmaceutical, biologic, medical device, combination products and more, in accordance with regulatory expectations for route of administration, formulation, dosage, container-closure system and drug delivery device requirements, ensuring patient safety and expediting time to market.

Regulatory agencies require the impact of extractable and leachable substances on safety and drug product interaction be studied and evaluated throughout the drug development process to make certain drug efficacy and patient safety are not compromised. E&L studies determine whether potentially harmful organic and inorganic impurities that can alter product safety or effectiveness have migrated into the finished product from container-closure systems, manufacturing components, process equipment, packaging or delivery devices.

Element’s regulatory and scientific experts support the world’s leading healthcare brands in establishing the safety of materials for patients. An in-depth understanding of regulatory expectations, from materials assessment to toxicological evaluations, decades of experience developing and executing extractables and leachables programs, one of the largest extractables databases in the industry, and a history of proven success supporting complex dosage forms, serve as the foundation for the industry-leading, comprehensive E&L solutions we offer.

Extractables and leachables regulatory expectations

Regulatory agencies, including the FDA, EMA, MHRA and Health Canada, require that all new drug application (NDA) and biologics license application (BLA) submissions contain E&L data, and although general guidance regarding the approach and standards for E&L testing has been made available by the FDA, USP and EMA, the procedures are not prescriptive. A thorough understanding of acceptable protocols and reports is critical, as following the wrong study protocol can result in costly delays, particularly for biopharmaceutical regulatory submissions, which require packaging safety and toxicology studies. Likewise, for combination products and medical devices, a deep understanding of ISO 10993, the primary source of regulatory information, is needed to properly evaluate requirements to successfully design and deliver a comprehensive extractables and leachables testing program. Furthermore, cell and gene therapies present several unique challenges for E&L testing, and the initial materials and risk assessment is of particular importance, as efficient commercialization is dependent upon E&L process qualification in early clinical development.

Element’s in-depth knowledge of regulatory guidance, materials science and advanced equipment results in the efficient and successful completion of extractables and leachables testing programs for container closure systems (CCS), including combination products, implantable medical devices, drug delivery and infusion systems, large molecule drug products including cell and gene therapies, and single-use systems (SUS) for commercial manufacturing, including BioPhorum Operations Group (BPOG) extractables testing protocols.

The Element advantage

With one of the largest and most experienced E&L practices in the world, in addition to unparalleled experience testing a breadth of products that extend from pharmaceuticals, biologics and devices, to electronic nicotine delivery systems (ENDS) and more, as your regulatory and scientific partner, Element will help you to navigate the most efficient path to regulatory approval. Our team of engaged experts have directly contributed to the industry for years, serving as active participants in several working groups that have developed the PQRI, USP Expert Panels, ELSIE and BPOG extractable and leachable best practices.

For more information about our extractables and leachables studies and consulting services, or to request a quote, contact us today.