Forced degradation studies of biopharmaceuticals

RSSL can assist in designing forced degradation studies using insightful feasibility analysis to identify CQAs or produce biosimilarity/comparability data.

 

To fully characterise biological products, it is necessary to define the degradation pathways by which they can be converted into other forms. However, if determined in real-time with stability studies, this process could take several years.  

 

At RSSL, we apply forced degradation conditions - temperature, pH, redox, light, humidity and shear stress - to accelerate this process. This enables the production of enough drug degradation products (5-20%) to be useful in stability indicating method development and validation. 

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In addition to conducting the studies, our technical experts can also build a robust regulatory compliant data package to support your regulatory submission.

 

Forced degradation studies are used to:

 

  • To identify natural degradation pathways and mechanisms (early phase work) 
  • To identify stability indicating characteristics 
  • To produce degraded material for impurity identification, assay testing and validation 
  • To gain additional information about the drug molecule 

 

 

To identify the optimal conditions, each drug will require a tailored forced degradation protocol. This optimisation is performed using a robust feasibility study resulting in the development of a bespoke method capable of achieving suitable drug degradation levels.

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