Healixe Introduces HPTLS: Rapid, Accurate NIR Spectroscopy for Surfactant Analysis
Healixe has introduced High-Precision Tunable Laser Spectroscopy (HPTLS), a next-generation near-infrared (NIR) spectroscopy technology, designed to revolutionize the analysis of surfactants in biopharmaceutical formulations. This innovative method promises rapid, accurate, and cost-effective quantification of excipients, even at low concentrations.
HPTLS focuses on the combination band region (2100-2400 nm) of the electromagnetic spectrum, providing greater spectral specificity and enhanced resolution in complex biopharmaceutical matrices. This allows it to maintain consistent results under different formulation conditions, including the presence of sugars, buffers, and protein, without matrix-specific calibration.
One of the most commonly used surfactants in the pharmaceutical industry is Polysorbate 80 (PS80 or Tween-80), present in most commercial monoclonal antibody formulations. However, its low concentration between 0.1 and 1 mg/mL makes detection and quantification challenging with conventional analytical techniques. HPTLS empowers scientists to monitor PS80 levels more frequently, confidently, and cost-effectively, accelerating formulation optimization and supporting regulatory compliance.
Regulatory agencies expect excipients such as surfactants to be appropriately selected, justified, and characterized throughout the product lifecycle. HPTLS delivers rapid NIR analysis, determining analyte concentrations with HPLC-like accuracy in under three minutes, without extraction steps or specialized operators. Accurate quantitation of PS80 is essential for formulation optimization, aggregation prevention, product quality and safety, and regulatory compliance.
HPTLS, developed by Healixe, offers a faster, more accessible alternative to HPLC for surfactant quantification in biopharmaceutical formulations. Its ability to maintain consistent results under varying conditions and its focus on low-concentration excipients like PS80 make it a valuable tool for scientists and regulatory bodies alike.
