My introduction to Differential Scanning Calorimetry (DSC) was a postdoctoral fellow in the late 1980s. I was producing mutant forms of the enzyme thymidylate synthase, and I needed to characterize the effects amino acid changes had on the overall stability of the protein. Using a DSC instrument at our facility, I compared the thermal stability of the different mutants to wild-type protein by ranking the thermal transition temperature (TM). As I recall, I needed about 2 mg -4 mg protein per DSC experiment, which was a lot of protein at the time! Plus, each experiment took several hours to perform. But the value, quality and the reliability of the DSC data generated made it worth the time and sample consumption, and thermal stability characterization was important to progressing my research.
In the thirty years since my initial DSC experiments, there have been many advancements in DSC instruments, including decreased sample consumption, automation, and improved data analysis tools. During these same thirty years, the biotherapeutic industry has ‘exploded’ and is now a multi-billion-dollar industry with huge growth potential. Characterizing protein stability is key to biotherapeutic protein development, and stability must be assessed and reviewed from candidate selection and formulation development, all the way through to batch-to-batch comparability or biosimilarity assessment, not forgetting manufacturing support and process changes! We need objective, reliable stability data to have confidence in our decisions about which drug products and processes to move through development and into commercialization.
In the past 15 years, as an applications scientist specifically supporting microcalorimetry, I have helped biopharma companies incorporate DSC stability assays into their drug development pipeline. I have also heard from DSC users about the tools they believe would make DSC easier to use in biopharmaceutical development.
Malvern Instruments is proud to unveil the new MicroCal PEAQ-DSC Automated system – the ultimate solution for every laboratory involved in the assessment of biomolecular stability and biocomparability – one technology to provide high-throughput, automated operation for all users. We have designed a stability characterization technology for the regulated environment that is easy-to-use and delivers artifact-free data with unrivalled detail and reproducibility, which will give you true confidence in your results.
Please join my colleague Dr. Ronan O’Brien on February 21st 2017, and be one of the first to see how the future of protein stability analysis has been transformed.