DSC for the regulated environment
Advancing biotherapeutic molecules along the drug development pipeline is a complex, time-consuming and expensive process. Good stability is key to a candidate’s progression, and must be assessed and reviewed throughout development – from candidate selection, through formulation development, all the way to batch-to-batch comparability or biosimilarity assessment….and beyond! Objective, reliable stability data is needed for confident decision-making about which drug products and processes to move through development into commercialization.
Differential Scanning Calorimetry (DSC) is a biophysical tool for protein stability characterization. The MicroCal VP-Capillary DSC system, launched in 2002, was the first automated DSC specifically designed for use during biopharmaceutical development. The automation and software tools of MicroCal VP-Capillary DSC established the technique in formulation development, candidate selection and process development, and DSC assays are also used throughout development and manufacturing as a comparability assay. The development of biosimilars has been advanced by the use of DSC during comparability evaluation, when the DSC profile of the biosimilar is assessed in comparison to that of the innovator (parent) drug.
Malvern Instruments is excited to unveil the new MicroCal PEAQ-DSC systems – 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, to give you absolute confidence in your results.
Please join 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.
Choose the right time for you and register now!
Speaker: Ronan O’Brien, Ph.D., Head of Business Development for MicroCal product group, Malvern Instruments
Ronan has a Ph.D. in Biophysical Chemistry and spent many years working in the area of label-free interaction analysis, and has published articles in scientific journals and reviews. Ronan did his post-doctoral research with Professor Julian Sturtevant at Yale University and Professor John Ladbury at University College London, before joining MicroCal as an applications expert in 2001. Ronan has held a number of roles within the MicroCal business, including Scientific Marketing Manager and Head of MicroCal R&D, before taking his current position as Head of Business Development for the MicroCal product group at Malvern Instruments.
For more information on use of DSC in biopharmaceutical development:
- Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Candidate selection for developability
- Characterization of biopharmaceutical stability with Differential Scanning Calorimetry: Preformulation and formulation development
- Characterization of biopharmaceutical stability with Differential Scanning Calorimetry