CMC Biologics provides cGMP stability studies to estimate shelf life for active pharmaceutical ingredient (API), intermediates, drug product, placebo, and reference standards.
The services include:
- 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
Stability studies may be designed to meet our customers’ specific needs or to follow ICH guidelines. 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 additional services, such as method development or validation activity.
Our capabilities include biochemistry, HPLC, characterization, cell-based assays, and microbiological testing services and support in a GMP laboratory. A subset of the specification analyses will typically be stability-indicating.
The storage capacities are according to ICH guidelines and include:
- Ultrafreezers (-80°C)
- Freezers (-20°C)
- Refrigerators (2-8°C)
- Climate chambers (+25°C 60% RH, +30°C 65% RH, and +40°C 75% RH)
Other storage conditions can be provided as needed.
CMC Biologics stability team offers you:
- Complete service from the stability protocol to the stability report
- Stability study design and protocol generation according to specific needs
- Secure storage equipment dedicated to stability studies, with 24-hour computerized monitoring system with backup capacity to ensure proper study execution
- Increased vendor management efficiency by having stability studies performed by CMO rather than at a subcontractor
- Analytical methods that are implemented and validated in connection with cGMP manufacturing
- QC and QA review of data with QA-approved test results for each time point according to agreed timelines
- Fast turnaround times for each time point