Drug Discovery & Development

Small Molecule Drug Discovery

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Downstream Purification Development

Formulations

Long Term Stability

Stability Characterization

Excipient Screening

Manufacturing and QC

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Stability of Liquid Biopharmaceutical Formulations

To arrive at the correct liquid formulation quickly is of paramount concern for the biopharmaceutical industry. The design of experiment to conduct traditional long-term solution stability studies involves the storage of protein solutions of different concentrations in various buffer systems (with or without added excipients) under several stress, temperature, and/or lighting conditions. Regulatory agencies call for the use of stability indicating assays in the assessment of biotherapeutic stability and shelf life. Because stability predictions made with Differential Scanning Calorimetry (DSC) correspond well with those of longer-term studies (e.g. SEC aggregation studies), microcalorimetry has become an invaluable tool to rapidly screen protein stability in solution.

DSC enables rapid, accurate, and easy to perform measurement of the thermal transition midpoint (T_m), which has proven to be exceptionally good indicator of the relative stability of liquid formulations. Used as a stability-indicating assay, DSC can identify good formulations candidates earlier for further downstream processing. By culling formulations that are likely to fail early and focusing on those that are more viable for real time and accelerated stability studies, the use of DSC can result in a savings of both time and money.

Why use DSC for biopharmaceutical formulations development?

Easily determine optimum solution conditions.
Rapidly reduce the number of formulations processed downstream.
Save time and money spent on drug substance and complex analytics.
Expedite the development of a biotherapeutic using optimized formulations for accelerated and real-time stability studies.
Predictive tool that corresponds well to industry standards for assessing long-term stability.
Predict the tendency to aggregate.
Easily determine the stability contribution of individual excipients.

Both DSC and Isothermal Titration Calorimetry (ITC) can aid in understanding the effects that excipients and adjuvants have on final formulations of biotherapeutics and vaccines. DSC can be used to determine the stability contribution of individual excipients as well as identify the mechanism of stabilization for a particular biotherapeutic. ITC can be used to identify the mechanism of stabilization by characterizing the binding of excipients used in a formulation. ITC can also be utilized to assess whether excipients or adjuvants interfere with or facilitate the binding of the biotherapeutic or vaccine to its target.

Reference List

DSC-Liquid Protein Formulation Studies Reference List

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