Biopharmaceutical Stability Testing

Biopharmaceutical products are highly variable and, relative to pharmaceuticals, generally require more controlled conditions to preserve product potency, function and safety. They have lower handling tolerances to temperature, require more stringent containment methods to avoid contamination and are more susceptible to agitation and vibration. Additionally, biopharmaceuticals tend to be more susceptible to degradation when faced with changes in their chemical environment. These include changes in pH, ionic strength, the presence or absence of metal ions, surfactant type and surfactant concentration.

As a biopharmaceutical company, you need to provide evidence of the stability and quality of your drug substance or drug product throughout its lifecycle, from production through storage and distribution, under both expected and unexpected conditions. ICH, EMA, WHO and FDA guidelines require shelf lives of all drug substances and drug products to be monitored via stability testing.