Forced degradation is the process of subjecting drug compounds to extreme chemical and environmental conditions to determine product breakdown levels and preliminary degradation kinetics, and to identify potential degradation products. They are used to facilit ate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products. It is particularly useful when little information is available about potential degradation products. In addition to develop stability- indicating analytical methods, these studies also provide information about the degradation pathways and degradation products that could form during storage, transportation.
Forced degradation studies may help facilitate pharmaceutical development in areas such as formulation development, manufacturing, and packaging, in which knowledge of chemical behavior can be used to improve a drug product.
Forced degradation studies / Stress studies
Stress studies at Protagen Protein Services (PPS) will be performed according to ICH Q1A.
The aim of stress studies is to identify degradation products and resulting degradation pathways. Thereby, suitable analytical procedures can be developed and validated. Furthermore, studies under stress conditions may be useful in determining the effect of accidental exposures to conditions other than those proposed (e.g. during transportation).
Stress studies are required throughout the entire development of biopharmaceuticals. We perform stress studies ideally prior to method validation to also be able to use the generated stress samples for method validation.
Forced degradation products can be generated by e.g. oxidation stress, pH stress, temperature stress, agitation stress or freeze / thaw stress.
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:
- Clone Selection & Process Development
- Extendend Characterization & Comparability
- Stability & Release
Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science. More than 20 years of market experience and the comprehensive spectrum of validated analytical methods ensure the highest quality for customers in the pharmaceutical, biotech and life science industry.
PPS supports Biosimilar developers with a broad range of analytical methods and consulting in achieving and demonstrating Biosimilarity