Institute for International Research

Course Description

This course details the technical, regulatory and quality practices necessary for setting specifications for a wide variety of biological and biotechnological products. The roles of specifications and control limits in a total quality system are emphasized. Justification for the selection and validation of stability-indicating analytical methods and the establishment of suitable shelf-life specifications is discussed. The scope and objectives of specifications used to release and monitor pre-clinical lots, clinical lots and commercial lots are compared. The types of stability and validation data that should be generated to support specifications are presented and you will learn the regulatory requirements for setting specifications, and the rationale behind them.

Who Should Attend?

This course is designed for scientific, regulatory, and quality personnel involved in setting and supporting specifications and control strategies for biotechnology-derived drug products, including managers, supervisors and staff members from R&D, Production, QC, Statistics, Quality Assurance and Regulatory Affairs groups.

Complete Course Agenda

Regulatory Overview

• The interrelationship between lot release parameters and product shelf life
• The role of specifications in Quality by Design
• Review of FDA and ICH regulations and guidance documents
• Information included in CTD sections for bulk drug substance and final drug product
• The relationship between drug product stability and time in bulk storage

Analytical Methods for Biological/Biotechnological Products

• What technologies are appropriate and necessary for different product types
• Analytical methods used for product characterization, release, and stability testing
• The utility of and the design of systematic forced degradation studies to assess stability-indicating method capabilities and product stability

Statistical Considerations

• Optimal statistical design of stability studies to minimize variability and thereby risk
• Choosing a mathematical model and regression analysis
• Combining and extrapolating data
• Strategic method validation to identify key sources of variability
• Setting release specifications

Specifications for Development vs. Commercial Batches

• Preliminary specifications to support preclinical studies
• Use of stress studies to bracket shipping and handling conditions
• Specifications and stability for early versus late phase clinical trial batches
• Establishment of shelf life specifications
• Stability studies incorporated into pre and post license comparability protocols

Maintenance of Specifications

• Elements of specification maintenance
• Goals and purposes of ongoing stability studies
• Statistical considerations (number of lots, data points, time intervals, etc.)
• Updating the estimate of the product stability
• Demonstrating comparability of stability

Course Instructors

William Egan, Ph.D., Vice President, PharmaNet Consulting, Inc.
William Egan has over 30 years of experience in the technical, quality and regulatory requirements of biopharmaceutical product development and commercialization. Bill spent 28 years in various capacities at the Center for Biologics Evaluation and Research (and its precursor organizations) and was the Acting Director for the Office of Vaccines at the time of his retirement in January 2005. Bill is an expert in biologics CMC issues, including biotechnology product characterization, release and stability testing, and product and process comparability studies.

Timothy Schofield, M.S., Senior Director, Merck Research Laboratories
Timothy Schofield is a Senior Director in the Nonclinical Statistics department of Merck Research Laboratories, West Point, PA. He received a Bachelor of Science degree in mathematics in 1973 from Lafayette College, Easton, PA, and a Master of Science degree in statistics in 1976 from the University of Pennsylvania in Philadelphia. Tim currently heads the Nonclinical Statistics unit, consisting of 18 full-time statisticians who support development of Merck drugs, vaccines, and biologics.