Extractables and Leachables in Early Phase Development

Why Should You Attend:

For many years, it has been more or less conventional wisdom that E&L data is a late-stage development concern, but current trends suggest this is changing. In recent months, the FDA has required multiple drug sponsors to provide detailed E&L packages and/or address specific questions in relation to E&L as early as Phase I. Questions have not only involved clinical trial container/closures systems, they also have signaled concern about equipment used in manufacturing of materials and devices used for dosing (i.e. infusion sets).

Unanticipated regulatory scrutiny has caused several programs to be placed on clinical hold pending submission of E&L data, resulting in development delays and unplanned expense. This presentation will review regulatory trends, the nature of questions sponsors have been required to answer, and the types of programs encountering these issues. It will also provide guidance on how to design phase-appropriate E&L programs to address early phase expectations.

Learning Objectives:

• Understanding where extractables and leachables come from
• Learning the regulatory expectations and trends for extractables and leachables in early phase development
• Understanding which products may require E&L data in early phases
• How to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs

Areas Covered in the Webinar:

Background and Overview of Extractables and Leachables

• What are extractables and leachables
• Where do they come from
• Why is there concern

Regulatory Requirements of Extractables and Leachables

• What is required for E&L

Current Regulatory Trends - Early Phase Development

• What is being requested and why
• Review of what types of products are getting E&L requests – are there any trends
• Designing E&L studies to meet the unique needs of early phase development

Who Will Benefit:

• Drug Development Professionals
• CMC Analytical Chemists and Leads
• Manufacturing
• Quality Assurance
• Regulatory Affairs
• Program Management
• Clinical Leads

Wayland Rushing
Sr Scientific Advisor, ABC Laboratories

Dr. Wayland Rushing is a technical expert in chemistry, manufacturing and controls (CMC) program design, analytical development and regulatory submissions. Over his 15-year career, he 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. He currently serves on Parenteral Drug Association (PDA) advisory committees for Technology Transfer and Elastomeric Closures and Seals Presentation Summary and was co-author of PDA TR 65, Technology Transfer.

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