Cambridge Healthtech Training Seminars
August 3-4, 2015
DAY 1 1:00-5:15 pm • DAY 2 8:30 am-5:00 pm
(TS2) 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
Diane Paskiet, MS, Director of Scientific Affairs, West Pharmaceuticals
Ms. Paskiet has over twenty years of experience in polymer analysis relating to product failures, deformualtion and migration studies. She has served as a project advisor in support of qualification studies associated with container closure systems for IND and NDA filings. Her current responsibilities include coordination of studies for technical support and R&D. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories.
Each CHI Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch is “on your own”.
Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.
Those not attending a full training seminar, but who are registered for other tracks on those days of the conference, may participate in the training seminar sessions. We ask that those joining the seminars while they are in progress enter the room only during scheduled break periods to avoid disrupting the class in progress.