• Real time, long term stability studies
• Forced degradation studies
• Initial testing of stability indicating methods
• Freeze-thaw stability studies
• Photostability testing
• Shipment simulation studies
• Clinical Trial in-use simulation studies

Each study is individually designed to meet specific customer needs. Stability studies may either be developed individually or follow ICH guidelines and covers the complete service from the stability protocol to the stability report.

We provide secure storage and experienced testing of your samples according to your specified procedures and timetables. Our capabilities include biochemistry, HPLC, characterization, cell-based assays and microbiological testing services and support for your biopharmaceutical product in a GMP laboratory. A subset of the specification analyses will typically be stability-indicating.

Our stability group designs studies specific to your project needs with analyses of those attributes that are susceptible to change during storage. Our experienced analytical staff is available for any additional services such as method development or validation activity.

The storage capacities are according to ICH guidelines and include ultrafreezers (-80°C), freezers (-20°C), refrigerators (2-8°C) and climate chambers (+25°C 60% RH, +30°C 65% RH and +40°C 75% RH). Other storage conditions can be performed to cover your needs.

CMC Biologics stability team offer you:

• Design of your stability study and protocol generation according to the specific needs
• Storage equipment dedicated to stability studies with 24 hour computerized monitoring system to ensure proper execution of your studies with back-up capacity
• Valuable saving of management time placing your studies at your CMO and not at a sub-contractor
• Analytical methods that are implemented and validated in connection with cGMP manufacturing
• QC and QA review of data with a QA approved report for each time point according to agreed timelines
• Fast turnaround time for each time point