Related Experiment Video
Updated: Jun 19, 2026

Measuring Enzymatic Stability by Isothermal Titration Calorimetry
Published on: March 26, 2019
Consideration on a few aspects of the stability studies post licensure
I Pierard1, G Spelte, D Le Tallec
1GlaxoSmithKline Biologicals, Rixensart, Belgium. isabelle.pierard@gskbio.com
Abstract:
Stability studies represent a significant workload for both manufacturers and regulatory reviewers and therefore a careful selection of the study design and of the stability indicator test is required to make sure that the study will provide the relevant information. Moreover, alternatives to the existing regulatory approaches should be favoured in order to better or quicker analyze the impact of a specific change. In this article, examples of alternative approaches are given. For the stability monitoring study, emphasis is put on the bulk stability program. Concerning comparability stability study, two case studies illustrating how accelerated stability studies could be used to support manufacturing changes are presented.
Related Concept Videos
Drug Product Stability
Stability
The stability of an LTI system is determined by the roots of its characteristic equation, known as poles. A system is stable if it produces a bounded...
Stability of structures
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Design Consideration
The factor of safety is another key aspect...