The rapid increase in the development and manufacture of biotherapeutics, particularly higher-concentration injectable drugs, is driving demand for faster, more reliable capillary differential scanning calorimetery (DSC). But this seismic shift in drug industry interest has also shone a spotlight on capillary DSC’s shortcomings. Though a vital thermal-stability testing tool for ensuring product quality and safety, optimizing formulations and storage conditions, and securing regulatory approval, the technique’s small sample sizes, typically in the microliter range, can be challenging from a preparation standpoint. Such small volumes also make capillary DSC samples sensitive to contamination, necessitating time-consuming cleaning protocols.
If your lab needs faster and more efficient biological drug stability and quality testing, look no further than the latest Capillary DSC from Waters Corporation’s TA Instruments division. Dubbed Rapid Screening-Differential Scanning Calorimeter (RS-DSC), the instrument is uniquely designed to test high-concentration biologic formulations specifically for antibody drugs and engineered proteins.
RS-DSC features unique—and disposable—microfluidic chips (MFCs) that enable up to 24 simultaneous measurements at sample volumes 25 times lower than competing systems. These MFCs not only lower contamination risks, they also greatly reduce or altogether eliminate the need for sample dilution and repetitive instrument cleaning. RS-DSC also avoids the sensitivity challenges of differential scanning fluorimetry, enabling labs to procure more accurate data from high-concentration samples. New algorithms in the TA Instrument’s NanoAnalyze data processing software also facilitate analysis of large quantities of thermal data. All told, use of RS-DSC will significantly improve time to decision.
One demonstration using RS-DSC to evaluate high-concentration lysozyme solutions up to 330 mg/mL identified unexpected concentration dependence on thermal stability. In another application, the system delivered accurate and reproducible analysis of complex-multiple transition antibody samples and rapidly determined buffer component and mutation impacts on overall protein structure.
At the end of the day, RS-DSC delivers an easier workflow, increased rate of data acquisition through parallel testing, and faster analysis via automated peak detection algorithms. It is ideal for labs developing biotherapeutics and monoclonal antibodies to treat cancer, infections, asthma, rheumatoid arthritis, autoimmune diseases, and transplant rejection, and will increase efficiency at every stage of biopharma development where stability is a critical concern, including drug discovery, candidate selection, formulation and process development, and manufacturing.