Unlike small molecule drugs, large molecule drugs are biologically active and therefore, more easily affected by environmental conditions. To ensure an optimally-controlled, fully compliant CGMP environment for stability sample storage and handling, we use a fully validated Rees monitoring system, validated backup temperature and humidity charts and redundant chamber operating systems. We also have a 100% backup power supply to ensure consistent conditions in the event of a power loss.
ABC conducts stability studies in a secure, DEA-licensed stability suite that provides all ICH conditions, as well as photostability and custom conditions. In addition, we have 35,000 cubic feet of stability storage space--a capacity that is equivalent to 10 tractor trailers.