Desarrollo y calidad de procesos

Real-time spectroscopic methods like NIR and Raman spectroscopy, and gas analysis by Chemiluminescence method are used to monitor biopharmaceutical processes, ensuring consistent product quality and detecting deviations early (Quality By Design, QBD). It helps identify and quantify active ingredients, impurities, and other components in biopharmaceutical products, ensuring their identity and purity, and can be used to differentiate genuine biopharmaceuticals from counterfeits, safeguarding patient safety. Spectroscopy and Particle Size Analysis help ensure biopharmaceutical products meet strict quality and safety standards before release to the market. In addition to routine quality control, these same orthogonal, non‑destructive analytical approaches support pharma forensics by enabling the investigation of unknown impurities, process deviations, and counterfeit or compromised products—providing defensible data for regulatory compliance and product integrity assurance before and after market release.

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