Comprehensive Forced Degradation Studies to Validate Stability–Indicating Methods for Biotechnology Products
Introduction
Analytical test methods used to assess the stability of pharmaceutical products require validation to demonstrate that they are suitable for the intended use of measuring and monitoring product degradants. Several worldwide regulatory guidance documents mention the studies necessary for the appropriate validation of quality control test procedures. These include comprehensive, systematic forced degradation studies to generate product degradants with which to challenge the methods for their ability to resolve and detect different degradants.
Current and classical protein chemistry methods are typically utilized to assess the quality and consistency of a biotechnology product. A major quality attribute of biotechnology products is a ‘stability-indicating profile’. Simply put, it is the analytical ‘picture’ of product features as determined by orthogonal techniques that are sensitive and specific for product degradation. Beyond the impact of a loss of product potency, fragments, aggregates, and other modified forms of biotechnology products that are administered parenterally can trigger immunological events in patients such as anti-product antibodies.
Although most proteins have a common set of degradation pathways (e.g. oxidation, deamidation, aggregation, hydrolysis), each protein can generate a unique set of degradants under physical and chemical stress conditions. While early in product development it may be acceptable to utilize physiochemical test methods that are likely to be stability-indicating for most proteins, ultimately these methods must be empirically validated for each product’s unique set of potential degradants.
This live and interactive BenAstrum web training course will highlight the disconnects found in the validation of many methods claimed to be stability-indicating, outline the experimental details of comprehensive, systematic forced degradation studies, and illustrate how these experiments are used to produce a stability-indicating profile of protein biotherapeutics.
Discussion Points:
Defining a Biotechnology Stability-Indicating Profile
- Orthogonal test methods for various types of biotechnology products
- Potential degradation pathways for proteins
- Method validation parameters for QC release and stability methods
Outline of Forced Degradation Studies
- Overview of forced degradation experiment matrix
- Execution of physical and chemical conditions
- Review and analysis of study data to validate stability-indicating methods
Who Can Benefit:
This curriculum is designed for scientists and professionals interested in the subject matter in the biotechnology sector.
Please click here for the course agenda
