Process monitoring tools are essential throughout manufacturing, but the complexity of drug development makes it challenging to integrate robust process analysis into every phase without encountering logistical or financial challenges. At-line and off-line sampling techniques can be useful, but they are limited because the analysis they provide is conducted separately from the process. In-line analytics encompass techniques that monitor the product flow directly and therefore provide more accurate data.
Either way, Cambrex works closely with your development team to implement the appropriate monitoring strategy for your program needs, whether you are pursuing batch or continuous flow programs. We have the experts and the equipment to provide advanced monitoring, including ReactIR™ spectroscopy, Raman spectroscopy, focused beam reflectance measurement (FBRM), nuclear magnetic resonance (NMR) spectroscopy and more. Our general approach is to define critical process parameters for small-scale development batches, then scale back in-situ reaction monitoring for larger manufacturing runs, at which time we rely on general parametric data such as temperature, pressure and pH.
Integrated data acquisition capabilities are available at our High Point, NC, facility, which houses our continuous flow development lab, extensive analytics equipment and a cadre of analytical research development and process chemists who collaborate seamlessly to ensure the success of your project. Our acquisition of Snapdragon Chemistry also expands our capacity to offer an array of in-line and at-line process analytical technologies (PAT) for real-time monitoring and control. For example, Snapdragon Chemistry’s Sample Relay System (SRS™) enables online automated sampling and liquid chromatography analysis, and its LabOS™ monitoring and automation platform connects seamlessly with pumps, meters, PAT and more to support data-rich experimentation and flexible automation.