Stability studies provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of factors such as temperature, humidity & light
Intertek, a leading quality solutions provider to industries worldwide, will formally launch the expansion of stability storage and testing studies to support development of complex pharmaceuticals such as inhaled or biologic medicines at the CPhI/ICSE Exhibition in Paris, 7-9 October 2014, on stand 1F71.
Stability studies provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of factors such as temperature, humidity and light. This allows recommended storage conditions, re-test periods and shelf lives to be established.
A new Good Manufacturing Practice (cGMP) compliant stability storage facility located near Cambridge in the UK has more than tripled the GMP stability storage capacity. This is integrated with specialist testing expertise for inhalation devices such as laser particle sizing, aerodynamic particle size distribution (APSD) by impaction (ACI, NGI) and spray pattern/plume geometry.
Biologics also require specialist testing. Services are aligned to determine and monitor stability indicating parameters such as protein structure and activity throughout formulation and storage.
'This combination of storage capacity integrated with our scientists’ knowledge of inhalation and biologics testing help meet the increased demands from our global clients for product quality characteristics profiling for regulatory purposes,' says Mark Hammond, Laboratory Directory.
Chetan Parmar, Senior Vice President of Intertek Life Sciences, commented: 'Assessment of a pharmaceutical product’s stability is an important aspect of the development process. With our global stability study capability we can support our clients in their development of complex products which require specialist knowledge and analytical experience.'
GMP stability testing forms a key part of Intertek’s laboratory services supporting chemistry, manufacturing and controls (CMC) client activities. Intertek’s global ICH stability storage and testing locations also include Manchester (UK), Whitehouse, (New Jersey, USA) and Melbourne, (Australia). Early stage development stability services include excipient compatibility, stability profiles of the active pharmaceutical ingredient (API) and early formulations. Confirmatory stability services include long term and accelerated studies on the product prior to registration.
Intertek has a 20 year heritage providing cGMP contract analytical and formulation support, bioanalysis and regulatory affairs services.