New Stability Building doubles capacity; offers storage-only and storage/testing options
Stability programs are a critical component to advancing drug development candidates and supporting marketed products. Identifying the optimum outsourcing partner with necessary cGMP storage capacity and conditions, study management expertise and broad testing capabilities is essential to a successful stability study. Eurofins Lancaster Laboratories has responded to the growing demand for stability study and storage support from its Bio/Pharmaceutical and Medical Device clients by investing in a new 17,000-square-foot stability storage facility to be completed end of 2016.
Now with the largest stability storage capacity in the US with 80,000 cubic feet of storage in 80 chambers, Eurofins Lancaster Labs offers the complete range of specialized conditions with cGMP storage-only and storage/testing options for clients’ marketed products, drug development candidates, and critical reference materials. All chambers are housed in secured areas, continuously monitored by validated monitoring systems and supported by a fully validated computerized stability laboratory information management system (LIMS) to manage and ensure proper execution of studies.
Advantages for our Stability Clients:
- A total of 80,000 cubic feet of storage in 80 chambers
- More than 25 different set points for stability chambers, including all ICH conditions
- All specialized storage conditions: temperature, light and humidity
- Large capacity, ultra-low temperature (-80oC) walk-in (equivalent to 36 reach-in chambers)
- Capacity for 10 additional LN2 cryogenic freezers
- Full stability and reference standard/critical reagent storage and testing, as well as storage only options
- Stability support including protocol writing and method development/ validation
- cGMP retain program management
- International Shipping Specialist to ship products and critical reagents anywhere in the world, navigating permitting, importing and customs
- Risk mitigation with redundant controls, 24-hour camera monitoring and backup generators
- Online data access portal LabAccess.comSM features stability calendar displaying study progress with sample number links to view live data
- Building designed to triple in size as client needs grow
Backed by a 55-year history of delivering comprehensive laboratory services and fostering thousands of client relationships, Eurofins Lancaster Laboratories is the outsourcing partner of choice for vast stability storage capacity, comprehensive storage conditions, risk mitigation, and cGMP compliant testing capabilities. For more information on the advantages of Eurofins Lancaster Laboratories’ new state-of-the-art stability building and GMP storage-only or storage/testing options, visit EurofinsLancasterLabs.com.