Impurities resulting from contact surfaces in the manufacturing process or in the final container closure system are referred to as leachables. These compounds can have a significant impact on the drug product’s safety and efficacy. Understanding the potential sources of these compounds and the analytical tools to detect them can be vital to a development program. Designing and implementing an extractables and leachables program can save significant time/cost in development and potentially avoid pitfalls, which may increase time to market.
Wayland Rushing, Ph.D., Senior Scientific Advisor, ABC
Dr. Wayland Rushing is a technical expert in CMC program design, analytical development and regulatory submissions. Over his career, Dr. Rushing has led CMC development programs for a wide array of bioPharmaceuticals, including parenterals, inhalation drugs, and other Pharmaceuticals with complex delivery systems.
Dr. Rushing is a subject matter expert in HPLC and GC method development and validation, extractables and leachables program design and regulatory submission requirements; has drafted multiple IND and NDA submissions; and assists ABC clients in responding to FDA deficiency letters. Dr. Rushing currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Defects.
Who Should Attend?
Pharmaceutical and Biotechnology companies, including VPs/Directors/Managers of
- Research and Development
- Product Development
- CMC Operations
- Technical Operations
Anyone involved in the decision-making process for outsourcing drug development services, particularly analytical services
Since 1968, ABC has been delivering analytical expertise in support of product development. But like the industries we serve, our company has changed. Today’s ABC offers more than superior science and quality data. Through development know-how, cross-disciplinary technical expertise, and deep experience across evolving regulatory frameworks, ABC delivers the kind of scientific insight that drives better outcomes.
ABC delivers product development and analytical testing services across all API and formulations for both large and small molecules. Our approach to outsourcing promotes relationships beyond a simple transaction. It facilitates collaboration, promotes quality, makes better use of resources, and helps us plan to have the right talent and resources when and where our clients need them.