Stability Studies for Biologics and Biosimilars
At Biofidus, we design and execute stability and forced degradation studies for biologics and biosimilars to answer one of the most critical CMC questions: How your drug substance (DS) and drug product (DP) behave over time and under stress.
Our services help you identify degradation pathways, develop stability-indicating analytical methods and generate regulatory-ready data to support shelf-life assignment, comparability and lifecycle management.
What Are Forced Degradation Studies for Biologics?
Forced degradation studies of biologics are a set of experiments designed to evaluate the stability of the active pharmaceutical ingredient (API) and drug product under exaggerated conditions. We expose your monoclonal antibodies, recombinant proteins, fusion proteins, ADCs and other biologics to a range of physical, chemical and environmental stress conditions
These forced degradation studies mimic and accelerate potential degradation pathways beyond normal storage to reveal critical quality attributes (CQAs) addressed and quantified by stability-indicating methods.
Comprehensive Analytical Characterization of Degradation Products
Our stability and forced degradation programs embrace complex and comprehensive analytical pipelines to identify and characterize degradation products and impurities that may arise during the product’s lifecycle, and to understand how they impact quality, safety and efficacy.
The results of these stability and forced degradation studies support improved process design, formulation selection, packaging choice and storage conditions, ensuring the long-term stability and consistent quality of your drug product.
ICH-Compliant Stability and Forced Degradation Study Services
Our vast experience and deep knowledge in assessing the impact of degradants allow us to predict whether your product can consistently meet predefined stability acceptance criteria.
Biofidus offers holistic, state-of-the-art stability and forced degradation assessment services according to the relevant ICH guidelines (e.g. ICH Q1, ICH Q5C) to:
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Accelerate the approval of your biologic or biosimilar
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Support comparability and process changes with robust stability data
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Provide regulator-aligned, stability-indicating method packages
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
