Early commercially available biological calorimeters developed in the ’70s were initially used to study the “protein folding” question as part of the drive to design proteins de novo. Differential scanning calorimetry (DSC) in more recent years has found its niche in the formulation and development of biotherapeutic drugs, an area dominated by monoclonal antibody drugs which are well characterized by DSC. This application space has become so mainstream that the latest DSC instruments have ’21 CFR part 11’ compliance software so that DSC can be used in this heavily regulated environment and even in QC labs. It has proved invaluable for studying many new drug modalities such as RNA therapeutics and antibody-drug conjugates which are far less well understood with regards to their ‘shelf life’ and developability.
Changing times, new challenges
In more recent times the spread of the global pandemic has created new and urgent challenges, and a range of different types of molecules needing characterization. More attention is now being placed on delivery systems such as lipid nanoparticles (LNPs) and viral vectors. As a result of this rapidly evolving landscape, DSC has been utilized in new ways. Not surprisingly, some new measurement needs have evolved. As part of our experience in the recent collaboration between Malvern Panalytical and Leukocare we learned about the challenges arising from working in labs classified as Biosafety Level 2 (BSL-2). In response to feedback, we have performed risk analysis and implemented changes to facilitate routine cleaning and decontamination of our MicroCal Automated PEAQ-DSC while minimizing exposure to the user.
DSC in Biosafety Level 2 labs
Are you studying viruses and viral vectors, toxins, infectious agents, pathogens, or infectious organisms which pose a moderate hazard to humans or the environment? Are you using DSC for characterization? Download our latest v1.6 software now and set up decontamination cleaning protocols to enable automatic daily disinfection and syringe decontamination. The new software includes protocols that use a 2nd “fast wash” pump that is already on the autosampler. The decontaminant reagent is delivered using this pump to decontaminate the DSC sample syringe and/or the DSC cells and valves. Read our Technical Note for more details on setup and implementation.