Stability and Specifications for Biological and Biotech Products

Description

Stability programs are used to establish the shelf life of new or improved products, and to assure the continued compliance of product to the manufacturer's specifications. The logic surrounding setting shelf life claims or release attributes, and continued monitoring of manufactured material, should be considered carefully in light of the risks to the consumer and manufacturer alike. Understanding the roles of specifications and manufacturing control limits is critical to a risk based quality system. Those risks may be managed through strategic design and statistical analysis of the studies that support product control. This workshop will delineate the several uses of stability studies to establish shelf life and monitor product, and consider the critical inter-relationships among these various sources of stability data.

Instructor

Timothy Schofield, MA, Managing Director, Arlenda, Inc.
Timothy Schofield is Managing Director of Arlenda, Inc., where he provides nonclinical statistical support to the pharmaceutical industry. Prior to joining Arlenda Tim worked in the Regulatory Affairs department of GSK supporting US licensure of vaccines, and at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. Throughout his career Tim has collaborated with regulators and industry on stability evaluation of biologics and vaccines, and has coauthored industry papers on specifications and Quality by Design for biologics. Tim was the lead author of USP Chapter <1033> Bioassay Validation, and is vice chair of the USP Statistics Expert Committee. Tim led the control strategy subteam of the Quality by Design vaccine case study, and is co-chair of an industry/regulatory consortium which is developing a white paper on vaccine clinical assay development, validation, and maintenance. He received a Master of Arts degree in statistics in 1976 from the University of Pennsylvania in Philadelphia.

Course Agenda

• Basic Principles of Stability and Specifications
  • Goals of stability studies throughout the product lifecycle
  • Principles of kinetics
  • Accelerated and stress stability studies
• The role of statistics in stability and specifications
  • Interpreting statistical results
  • Scale of analysis and other statistical "potholes"
  • Using statistical design to improve information and reduce risk
• Modeling Stability Data using Regression Analysis
  • Modeling first order kinetics
  • Goodness of fit and detecting nonlinearity
  • Fitting nonlinear kinetics
  • Shelf life determination per ICH Q1E: Evaluation of Stability Data
• A Rational Approach for Setting Specifications
  • Fundamental principles of specifications
  • Specifications and Quality by Design
  • Clinical support of specifications
  • Release and manufacturing models
• Maintaining Specifications Post Licensure
  • Ongoing stability studies: goals and issues
  • Comparing stability after a process or facilities change