Stability Testing

Almac provides a complete cGMP stability testing service, encompassing protocol design, study management and analysis.

Our state-of-the-art, walk-in rooms provide comprehensive ICH-compliant, climatic storage facilities. All conditions are continually monitored, with back-up systems ensuring a totally secure and controlled environment.

Almac’s dedicated and experienced stability team are currently managing over 150 live programmes, including full ICH method development and validation. This capability enables us to conduct stability studies on both API and a diverse range of drug products.

We have the enviable capability to provide core stability testing services, but together with bolt-on, world-class, synthetic organic chemistry expertise.

This enables our guidance and elucidation on likely degradation pathways, and provision of degradation product synthesis. Accordingly, reference standards can be synthesised and used to identify and quantify degradants throughout the stability programme.