Ensure Raw Material Consistency with High-Resolution FTIR Analysis using the CLADETM MIRA Analyzer.
Raw material variability is a critical risk in biopharmaceutical manufacturing, impacting product stability, efficacy, and regulatory compliance. Here we want to highlight a use case of Raw Material Control of the widely use surfactant Polysorbate. We compare Polysorbate20 (PS20) from different suppliers that can exhibit subtle but significant differences, affecting formulation performance. Ensuring consistency is essential for maintaining batch-to-batch reliability and product integrity.
With our state-of-the-art FTIR spectroscopy system, we provide precise raw material fingerprinting— in aqueous samples. Our method requires zero sample preparation, making it ideal for fast and effective quality control within four minutes.
The spectral data below illustrate variations between PS20 batches, demonstrating how FTIR can detect critical differences in raw materials. Whether you need to validate suppliers, investigate deviations, or optimize formulations, our technology delivers the insights you need.
Browse the spectra, see the difference in the spectra. for yourself. Heres a hint, zoom into wavenumber 1550 cm-1 to see the minute yet significant difference, suggesting contamination of this batch of PS20.
Ensure your raw materials meet the highest standards and contact us to today to discuss your raw material control needs.