Monitors the impact of temperature and humidity on pharma product quality
LGC, an international life sciences measurement and testing company, has launched a stability testing service, adding to the established drug development services delivered from its Fordham, Cambridgeshire site in the UK.
The new service enables continuous recording and monitoring of essential data on the impact of environmental factors, such as temperature and humidity, on the quality of a pharmaceutical product.
LGC provides on-site stability storage at a range of ICH (International Conference on Harmonisation) and non-standard conditions for long-term stability, accelerated stability and photostability assessment of clinical trial material, actives and finished product. The conditions in the stability chambers are continuously monitored by automated systems and benefit from full back-up power supplies.
Jeremy Cook, Managing Director, Laboratory and Managed Services at LGC, said stability testing further extends the company's drug development portfolio.
'In doing so, we can establish either a retest period for a drug substance, or a shelf life and recommended storage conditions for a manufactured product, which are all essential to minimising market risk and helping us towards our vision of using our science for a safer world,' he said.
With the acquisition of Quotient Bioresearch's bioanalytical business in December 2012, LGC now has vast experience in high-integrity analytical science and expertise spanning small and large molecules, biomarkers, molecular biology and microbiology.
Operating from state-of-the-art facilities to GLP, GCP and cGMP standards, the company also has leading capabilities in CMC, with particular specialities in materials science and a wide range of CMC analytical services.