Functional Application Areas

Biopharmaceutical and Vaccine Development

Biotherapeutics, such as antibodies and therapeutic proteins, and vaccines are being developed and manufactured for use against many disease indications. Stability is of paramount importance for their manufacturing and formulation as drug products because government agencies call for the use of stability indicating assays.  Differential Scanning Calorimetry (DSC) enables the rapid, accurate, and easy to perform measurement of the thermal midpoint (Tm), which has proven to be an exceptionally good indicator of the relative stability of proteins and other biopolymers.  Used as a stability indicating assay, DSC can provide insights for making critical decisions at every step in the development of a biotherapeutic or a vaccine.

DSC is used in biopharmaceutical and vaccine development to:

  • Serve as a predictive tool that corresponds well to industry standards for assessing long-term stability
  • Predict the stability of a biotherapeutic or vaccine under certain conditions (pH, buffer, salt, etc) before long-term stability studies
  • Predict the tendency to aggregate
  • Quickly and easily guide the selection of stable protein constructs during peptide, protein, or antibody engineering
  • Rapidly reduce the number of candidates processed downstream
  • Guide the selection of chromatographic methods before carrying out purification
  • Rapidly, in days compared to weeks, optimize loading and elution conditions throughout purification                    
  • Increase the efficiency and yield of biotherapeutic or vaccine purification resulting in substantial financial savings
  • Easily determine the stability contribution of individual excipients
  • Aid in identifying and understanding the mechanism of stabilization
  • Easily determine optimum formulation solution conditions
  • Rapidly reduce the number of formulations processed downstream
  • Expedite the development of a drug using optimized formulations for accelerated and real-time stability studies
  • Quickly and easily, assess the biocomparability of a drug product before  shipment
  • Easily determine guidance for optimal in-process storage and handling conditions before making critical decisions

For additional information on the use of DSC and Isothermal Titration Calorimetry (ITC) in biotherapeutic and vaccine development, please go to Biotherapeutics and Vaccines

Reference Lists

DSC – Protein Engineering and Mutagenesis Reference List

DSC – Liquid Protein Formulation Studies Reference List

DSC – Antibody Studies Reference List

DSC – Vaccine and Virus Studies Reference List

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