Stability & Release Testing Stability Programs & Release Testing for Large Molecule Drugs 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. Analytical Techniques Size-exclusion HPLC (SEC HPLC) Reverse Phase (RP HPLC) Ion Exchange HPLC (IEX HPLC) Peptide Mapping Gel Electrophoresis (SDS-PAGE) Isoelectric Focusing Gel Electrophoresis (IEF-PAGE) Bioassay Capillary Electrophoresis (CE) Capillary Isoelectric Focusing (cIEF) Western Blotting MS Analysis of Proteins (MS/MS, Q-Trap, TOF-MS) Glycan Analysis Our "phase-appropriate" approach to stability study design will help move your development program forward without unwarranted delays or expense.