TA Instruments has been a division of Waters since 1996. They focus on materials characterisation techniques as a function of temperature, implementing a range of techniques for biophysical properties characterisation. This presentation focuses on TA’s new high-throughput screening platform for analysing the thermal stability of large molecules and oligonucleotides, Rapid Screening DSC (RS-DSC).
Calorimetry techniques are considered the gold standard for the analysis of biomolecules in their native state. They can also evaluate other useful information through the tracking of thermodynamics, which provides useful insights into solution environments for biomolecules.
Mahey noted the rise in use of biologic therapies like antibodies, proteins, and oligos. Particularly, there has been an increasing demand for high concentration formulations which enable smaller dose volumes and administration at home in the form of subcutaneous or ophthalmic delivery.
However, developing formulations at high concentrations comes with its own set of challenges. These include stability issues such as protein aggregation, denaturation, and shelf life; and viscosity which complicates manufacturing and administration.
Therefore, robust analytical techniques are vital to ensure the quality of therapeutics made at these concentrations. The current methods available to measure thermal stability are differential scanning calorimetry (DSC) and nano-differential scanning fluorimetry (nanoDSF). However, there are limitations of conventional DSC and nano DSF techniques which highlight the need for a solution that combines high throughput with data quality.
TA Instruments sought to bridge this gap with their RS-DSC technology. This high-throughput platform is able to retain the quality of data that you’d expect from DSC while also measuring formulation strength concentrations, providing unique insights.
RS-DSC can analyse up to 24 samples simultaneously, requires less sample volume, and eliminates contamination risks with single-use chips. Furthermore, the tool can measure heat flow differences to determine thermal stability, capturing critical parameters such as maximum peak temperature and T onset.
The platform is applicable across various biologics, aiding in candidate selection and formulation optimisation, and is particularly effective for antibody and oligonucleotide stability studies. Its software features automated analysis tools for efficient processing of large data sets, enhancing the overall workflow in stability testing.
