Forced degradation is defined as the intentional degradation of a biotherapeutic to an appropriate extent by means of various stressing agents. The overall aim of such forced degradation (also known as stress studies) is to understand how a biotherapeutic may undergo degradation, whether this occurs during or following manufacture.

With the steady increase of industry regulators requesting host cell protein (HCP) quantification by techniques orthogonal to ELISA, UHPLC-MS has become the technique of choice for many pharmaceutical companies.

Colloidal stability is one of the most important properties to control due to the propensity for biopharmaceuticals to aggregate and the subsequent potential to severely affect the drug's efficacy and patient safety.

The potency assay for a typical biologic is usually the most complex assay in the release and stability specification. Potency methods should be designed to be as simple as possible to still reflect the mechanism of action (MOA) as is required in the regulations.