Monday, AUGUST 15 - Tuesday, AUGUST 16
Day 1 1:00-5:00 PM • Day 2 8:00 AM-5:15 PM


Introduction to Extractables and Leachables and Packaging

Chemical substances can be leached into biologics from various components used in the manufacture, storage or delivery of a therapeutic product leading to a negative impact on the product and potential for an undesirable effect on the patient. This training seminar will provide a background on regulatory expectations for materials and components in contact with biologics and the unique applications to biologic delivery systems. Sources of leachables will be realized by understanding components of delivery systems as related to the physical and chemical requirements for various delivery systems. Attendees will be shown how to design studies to understand material chemistry through extractable studies and correlation to potential leachables. These learnings will put into perspective the current regulations and provide a means to develop best practices to manage extractables and leachable issues by applying science and risk based approaches for assessing extractables and acquiring appropriate information to support regulatory submissions. Over the 1.5 days the following topics will be addressed.

A. Regulatory Expectations for Container Closure and Delivery Systems

  • Defining Extractables and Leachables with Respect to Biologics
  • Key Guidelines and Recommendations

B. Overview of Materials used to Manufacture, Store and Deliver Biologics

  • Common Materials and Components
  • Chemical/Physical Characteristics of Rubber, Plastic, Glass, Metal

C. Designing Studies to Qualify Materials for Intended Use

  • Requirements vs Recommendations
  • Establish Suitability for Use using Risk Based Approaches

D. Controlled Extractables Testing (CES)

  • Designing an Efficient CES
    • Sampling, Solvents, Time, Temperature
    • Analytical Methods for Analyzing Extracts
    • Interpreting Data

E. Leachables Studies

  • Identifying Targets
  • Best Practices and Thresholds
    • Analytical Methods
    • Safety Concern Thresholds
    • How Low to Go
    • Safety Concern Thresholds
    • Correlating Leachables to Extractables
    • Identification and Unknowns

F. Case Studies

  • Known Pitfalls and Risk Mitigation Strategies

Speaker information:

Instructors:


Diane PaskietDiane Paskiet, MS, Senior Director, Global Scientific Affairs, West Pharmaceuticals

Ms. Paskiet has over twenty years of experience in packaging and polymer analysis; primary areas of focus are related to product failures, deformulation and migration studies. She applies this knowledge to pharmaceutical container closure system qualification studies to support regulatory filings. Her current responsibilities include oversight of cross functional study plans and engagement in global educational forums. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and currently leading revision of USP Elastomers chapter. She is also Chair of the PQRI Parenteral and Ophthalmic Drug Product (PODP) Leachables and Extractables Working Group and a faculty member of the PDA Training Institute as well as author/co-author of papers on the subject of pharmaceutical packaging.

Fran_DegrazioFran Degrazio, Vice President, Global Scientific Affairs And Technical Services, West Pharmaceuticals

Fran DeGrazio has been in the pharmaceutical packaging industry for over 30 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, prefillable syringe systems and injectable combination products.Throughout her tenure at West, Fran has served in various functions within the analytical laboratory and research and development areas. Thirteen years were spent in the Technical Customer Service and Contract Laboratories areas with responsibility for strategic planning and implementation for both organizations. Fran was promoted to Vice President, Quality Assurance, Americas, in 2002 with responsibility for quality assurance and quality control for nine manufacturing facilities, the corporate analytical laboratories and the regulatory organization. In May 2006 she transitioned into the role of Vice President of Marketing and Strategic Business Development leading initiatives such as the concept of applying Quality by Design to closure development. As of 2012, Fran assumed a role as Global Vice President, Research and Development, Strategic Program Management and Technical Customer Support leading all packaging new product activities. As of February 2016, Fran was asked to develop a new organization for West. In this role, she will lead the Scientific Affairs and Technical Services organization for the enterprise. This role is focused on assuring West’s scientific industry leadership as we innovate new products and services for the market. Fran holds a degree in Chemistry from Cabrini College in Radnor, Pennsylvania, USA.

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