Forced Degradation Studies
Coriolis Pharma’s team of experts applies the knowledge gained from completing more than 1,500 projects to quickly and comprehensively design forced degradation studies that meet the needs of the study’s scope. Ultimately, we deliver the results of well-crafted studies that determine your product’s major degradation pathways and assess its critical quality attributes (CQAs).
Effective Forced Degradation Study Designs Carefully Balance Stress Conditions
Our team comprehensively considers ranging factors—carefully establishing stress conditions that neither overstress nor understress the drug substance—when designing forced degradation studies.
Conditions tested include:
- Freeze-thaw
- Temperature excursion
- Pumping
- Stirring
- Shaking/agitation
- Drop
- Light exposure
- Chemical spiking
- pH shift
- Oxidation
Forced Degradation Studies Designed for Your Drug Product
Our forced degradation study designs are backed by many years of experience with numerous therapeutic types, including highly concentrated protein formulations and active pharmaceutical ingredients like live virus vaccines and viral vectors that fall under biosafety level 2.
Your Phase
Our expert team has the analytical testing expertise and experience to design your forced degradation studies throughout the lifecycle of your drug development program.
Forced Degradation Studies Resources
Publications
August 1, 2018
Publications
Analytical Approaches to Assess the Degradation of Therapeutic Proteins
September 1, 2013
The Coriolis Effect
See how our expertise and comprehensive services accelerate biologics development from preclinical to the market.
