LGC has launched stability testing services, adding to the long-established drug development services delivered from its Fordham, Cambridgeshire site.
This 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 Harmonization) 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. With comprehensive method development, validation and cGMP analytical testing capability, LGC is able to effectively manage stability programmes to provide an integrated service to meet requirements.
Jeremy Cook, Managing Director, Laboratory and Managed Services at LGC said “We are delighted to be able to offer stability testing, which further extends our 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 minimizing market risk and helping us towards our vision of using our science for a safer world.”
With the acquisition of the leading bioanalytical business from Quotient Bioresearch in December 2012, LGC now has a world-class capability with more than 50 years’ experience in high-integrity analytical science and expertise spanning small and large molecules, biomarkers, molecular biology and microbiology.
Operating from facilities to GLP, GCP and cGMP standards, LGC also has leading capabilities in CMC, with particular specialties in materials science and a wide range of CMC analytical services.