Register Agenda Speaker Bios Event Presentation 1 Event Presentation 2
Link to Event Recording: USP Virtual Stakeholder Roundtable on Extractables & Leachables-20240826 1116-1.mp4
Overview:
Join industry, compendial, regulatory and scientific experts at the USP virtual open forum on August 26, 2024, to discuss the current challenges, technical and regulatory considerations for extractable and leachable testing of complex drug products.
The purpose of E&L testing is to identify and quantify substances released from the pharmaceutical container-closure, manufacturing equipment and bioprocess manufacturing systems during drug product manufacturing, which could affect the safety and quality of the drug product during manufacturing processes. Complex product formulations include complex injectables such as liposomes, suspensions, emulsions, microspheres, nano- and micro-particles, Peptide-device based products and large volume parenterals like infusion bags, a part ophthalmic products, nasals and inhalations, topical and transdermal drug products. Most of these formulations are difficult to develop and manufacture. These are very complex to establish meaningful analytical data due to complex matrices and low analytical evaluation thresholds and increased regulatory expectations in the extractable and leachable studies. E&L study is a risk-based approach and the testing for finished complex drug products is currently a subject of intense interest for the industry.
USP’s E&L open forum focuses on the technical considerations and challenges for E&L testing for various complex drug products, regulatory expectations in E&L assessment, need for the selection of appropriate standards, and case studies etc.,
The presentations in this Open Forum include topics related to:
- Repeatable Extraction studies
- Ophthalmic drug products
- Liposomes and Microspheres
- Transdermal products
- USP Updates on Extractable and Leachable
Why Attend:
You will have the opportunity to see, listen and ask questions to subject matter experts who are involved in E&L assessment and are involved in regulatory query management. They will provide information on creative solutions for various complex drug products.
Who Should Participate:
- Regulators & regulatory affairs professionals
- Research and development scientists and engineers
- Formulation/process development scientists
- Contract research /testing / CDMO’s
- Complex drug product manufacturers
- Analytical/process equipment manufacturers
- Academic researchers and students
Contact Information:
Ravikiran Kaja, Ph.D. Senior Principal Scientist Ravikiran.Kaja@usp.org.
For further information or to suggest additional stakeholder topics related to USP General Chapters please contact us at gc@usp.org.