Save Time and Money in Your Cold Chain via Dynamic Stability Testing
Stability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions established by the manufacturer at any time during manufacturing, distribution, and customer handling steps (e.g. bulk transport, filling and packaging operations, final product distribution operations, end user administration) intentionally (i.e. exposure) or not (i.e. excursion). The allowable time and temperature exposure to ranges outside of the long-term storage conditions for manufacturing is currently justified by using accelerated stability data gathered during static stability studies conducted under ICH guidelines.
However, these accelerated registration (or static) stability studies may be inadequate for the transport process especially when dealing with protein formulations in solution. The accelerated studies are normally terminated without returning samples of the exposed product to normal storage conditions and conduct assay testing to the end of shelf life to confirm product. The cumulative effects of other environmental hazards on product outside long-term storage recommendations are essentially unknown with standard static stability studies as currently recommended under ICH guidelines.