To fully characterise biological products, it is necessary to define the degradation pathways by which the product converts into non-active forms. This can be determined in real time with stability studies but these could take several years. This process can be accelerated by applying forced degradation conditions in terms of temperature, pH, redox, light, humidity and shear stress. The aim is to produce enough drug degradation products (5-30%) to be useful in stability indicating assay development and validation.

RSSL can help design your forced degradation studies based on insightful feasibility studies whether to identify CQAs or produce biosimilarity/comparability data. Our technical experts, can build you a robust regulatory compliant data package to support your regulatory submission.

Forced degradation studies are used:

• 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
• In formulation development
• To predict how a molecule will behave in formal stability studies under ICH conditions
• To provide a sensitive means of performing biosimilarity and comparability studies

Each drug will require a tailored forced degradation protocol to enable the optimum conditions to be utilised. This optimisation is performed using a robust feasibility study to identify optimal conditions resulting in suitable drug degradation levels.