DisperSol utilizes process analytics in pharmaceutical formulation manufacturing
DisperSol Technologies employs industrial analytics from Camo Analytics for real-time quality analysis in its pharmaceutical manufacturing process. The company is applying their unique KinetiSol® technology to the production of amorphous solid dispersions that enhance the bioavailability of poorly-soluble drugs.
DisperSol aims to implement real-time process analytical technologies (PAT) in their rapid fusion process in order to achieve in-line and at-line process monitoring and control in accordance with industry guidelines set by the FDA in 2004. To this end, they employ UV-vis reflectance and Raman spectroscopy. Robust analytics software for spectral modeling and real-time prediction is crucial. As DisperSol has moved to implement Unscrambler, Process Pulse, and Design-Expert software in their manufacturing processes, DisperSol and Camo Analytics have cultivated a collaborative working relationship.
Speed is the key
“We already analyze our product at-line using Raman spectroscopy. Camo’s Process Pulse allows us to monitor our product within seconds of manufacture to ensure the absence of residual crystalline drug and impurities,” says Angela Spangenberg, Research Scientist at DisperSol Technologies. “Our overarching goal, though, is to use rapid spectral analysis in order to control the process itself and terminate each mixing event at precisely the right time, without over- or under-processing. Because the material is converted in a matter of seconds, the key here is speed. We need to analyze several spectra per second,”.
DisperSol was founded in 2007 and evolved from a research collaboration with the University of Texas at Austin. The KinetiSol® process emerged from this research as an innovative technology for the production of pharmaceutical amorphous solid dispersions, in which the crystal lattice of a poorly-soluble drug is broken, rendering amorphous drug molecules dispersed in pharmaceutical polymers in order to enhance bioavailability and boost solubility. DisperSol is commercializing its technology platform through internal drug formulation development programs and external partnerships.
“From early on, it was not only clear that the Unscrambler gave us the capability to analyze our spectroscopic data; Camo’s willingness to provide thoughtful support was immediately apparent,” says Angela Spangenberg, who remembers an extremely accommodating attitude, when she first approached Camo Analytics. The Unscrambler is now used by several scientists at DisperSol. Since then the cooperation has evolved.
“We are still in the process of developing in-line spectral collection and analysis capabilities for the KinetiSol® process, but we are progressing rapidly towards real-time spectroscopic process control. The cooperation with Camo and the use of their products has been enabling in this effort,” says Angela Spangenberg.
“The team from Camo took on our challenge, and they worked with us and with our data. They visited our site four times during the early adoption of the Camo suite, and they demonstrated the software’s capability to handle our data first-hand. It is impressive to see this kind of commitment and cooperation from a vendor,” she says.
Prediction in milliseconds
In efforts to apply real-time spectroscopic analysis to the manufacturing process, DisperSol employs Camo’s Process Pulse software.
“Because our process is complete in less than a minute, the team at Camo ensured that their most recent version of Process Pulse enabled polling and prediction on a millisecond time scale. They even worked with ColVisTec, the manufacturer of one of our spectrometers in order to synchronize the communication between the spectrometer software and Process Pulse. By allowing us to rely completely on spectroscopic data to determine our processing endpoints, Unscrambler and Process Pulse are enabling us to control our process based on important product quality attributes, rather than relying on indirect cues such as processing time or temperature,” says Angela Spangenberg.
DisperSol collaborates with major pharmaceutical companies, chemical companies, and research institutions on applications of the KinetiSol technology to the most challenging drug molecules. DisperSol is capable in its Texas facility to support product development activities from preclinical development through to commercial GMP manufacturing.
“Our process is complete in less than a minute, and Camo ensured that Process Pulse enabled polling and prediction on a millisecond time scale.”
Angela Spangenberg, Research Scientist