New Method Speeds PS80 Quantification in Biopharmaceuticals
A new method, High-Precision Tunable Laser Spectroscopy (HPTLS), has been developed for rapid and accurate quantification of Polysorbate 80 (PS80) in biopharmaceutical formulations. This is significant as PS80 is a widely used surfactant in these formulations, aiding protein stability and reducing aggregation. The current standard methods, involving solid-phase extraction (SPE) followed by high-performance liquid chromatography (HPLC), are time-consuming and expensive.
HPTLS offers several advantages over HPLC. It focuses on the combination band region (2100-2400 nm) of near-infrared (NIR) spectroscopy, providing greater spectral specificity and enhanced quantitative performance. This allows HPTLS to maintain consistent results in different formulation conditions and complex matrices, without matrix-specific calibration. Moreover, HPTLS delivers rapid NIR analysis, determining analyte concentrations with HPLC-like accuracy in under three minutes, without external calibrations or specialized operators.
The development of HPTLS was a collaborative effort involving scientific teams worldwide, particularly those at the intersections of analytical chemistry, pharmaceutical technology, and biotechnology. Key contributions came from European groups in Germany and Switzerland, North American groups in the USA and Canada, and Asian groups in Japan and India. These teams published their findings in prestigious journals such as Analytical Chemistry and the Journal of Pharmaceutical and Biomedical Analysis.
The development of HPTLS as a method for rapid and accurate quantification of PS80 in biopharmaceutical formulations is a significant advancement. It addresses the challenges posed by conventional methods and offers a faster, more accessible alternative. This is crucial for regulatory compliance and ensuring product quality and safety throughout the product lifecycle.
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