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, reduced risk, 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 reduced risk products such as electronic nicotine delivery systems (ENDS) and, 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.
- USP <87> Biological reactivity
- USP <661> Containers – ophthalmics – plastics
- USP <1031> Biocompatibility of materials
- USP <1663> Extractables (pharmaceutical packaging/delivery systems)
- USP <1664> Drug product leachables (pharmaceutical packaging/delivery systems)
- USP <1660> Glass qualification
- USP <661.1> Plastic materials of construction
- USP <661.2> Plastic final packaging systems
- ISO-10993 Biological evaluation of medical devices (parts 18, 12, 17)
- Ph. Eur. Medicinal products for human use directive (2001/83/ec)
- Ph. Eur. 3.2 General sections on finished containers
Our in-depth regulatory insight, dedicated teams of E&L experts and industry-leading, extensive extractables database enable the development of robust strategies to evaluate risk and provide a solid risk-based set of supporting data for a variety of complex dosage forms and products, including biologics, cell and gene therapies, combination products and medical devices.
- Customized E&L study designs according to industry best practices and current regulatory expectations and guidance
- Development of E&L materials risk assessments and strategy documents suitable for regulatory submission
- Material selection for pharmaceutical container closure systems (CCS) and medical devices
- Complete method development and validation programs
- Controlled extraction studies
- Leachables method development and validation
- Extractable and leachable identification
- Leachable stability studies
- Drug and container-closure compatibility studies
- Toxicological safety assessments
- Comprehensive materials characterization and leachables risk evaluation according to ISO-10993 parts 18, 12 and 17
- On-site training and consulting programs
Extractables & Leachables Regulatory Guidance Services
Element provides regulatory guidance services for extractables and leachables to ensure that medicines are of the required quality, safety, and efficacy.
Extractables & Leachables Training Services
Element’s extractables and leachables training services address a wide range of topics in the industry to keep you up-to-date with the ever-changing regulations.
Extractables & Leachables Testing Reports
Element’s extractable and leachable testing programs are accompanied with clear, concise and accurate test reports.
Streamlining Extractables & Leachables Testing Protocols
Element helps you design effective and efficient extractables and leachables testing protocols to meet the risk-based approach and industry regulations.
ISO 18562: Biocompatibility Analysis
Element provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
On-demand Webinar: E&L Considerations for Customized Syringe Delivery
Dr. James Scull, Scientific Director for Element Life Sciences, discusses a case study that explores the E&L consideration of custom drug delivery systems in order to meet regulatory requirements.
White Paper: Embracing Agile Methodology for E&L Excellence
Adapting Agile product management methodologies to E&L programs adds flexibility to increase the likelihood for delivery of a supported leachable study in time for regulatory submission.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.
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