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Related Concept Videos

Applications of IR Spectroscopy: Overview01:11

Applications of IR Spectroscopy: Overview

The non-destructive nature and ability to provide valuable chemical information make IR spectroscopy a versatile technique with broad applications in various scientific and industrial fields. IR spectroscopy is commonly used to identify and characterize organic and inorganic compounds. It provides information about the functional groups present in a molecule and the bonding between atoms. This helps in the structural elucidation of compounds during organic synthesis, pharmaceutical research,...
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In argentometric precipitation titrations, endpoints can be detected visually by the Mohr, Volhard, and Fajans methods. In the Mohr method, adding a soluble chromate indicator gives an initial yellow color to the analyte solution. As the titrant is added, the first excess of silver ions forms a red silver chromate precipitate, marking the endpoint. The solution pH should be maintained at about 8 by adding solid CaCO3.
In the Volhard method, a standard excess of AgNO3 is first added to the...

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O-cresol Concentration Online Measurement Based On Near Infrared Spectroscopy Via Partial Least Square Regression
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Machine Learning-Based PAT Tool for Real-Time Residual Moisture Monitoring in Lyophilized Biopharmaceuticals Using

Samuele Fiorenza1,2, Mariapia D'Urso3,4, Ambra Massei5

  • 1Department of Information Technology and Electrical Engineering, University of Naples Federico II, Naples, Italy.

Biotechnology and Bioengineering
|July 12, 2026
PubMed
Summary

This study introduces a novel Process Analytical Technology (PAT) tool combining Near-Infrared Spectroscopy (NIRS) and Machine Learning (ML) for rapid, non-destructive Residual Moisture (RM) assessment in lyophilized biopharmaceuticals, enhancing process optimization.

Keywords:
lyophilized biopharmaceuticalsmachine learningnear‐infrared spectroscopyprocess analytical technologyresidual moisture monitoring

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Process Engineering

Background:

  • The pharmaceutical industry requires optimized analytical methods for efficient process development and manufacturing.
  • Process Analytical Technology (PAT) enables real-time process monitoring and control based on Critical Quality Attributes (CQAs).
  • Residual Moisture (RM) is a critical CQA in lyophilized biopharmaceuticals, traditionally measured by destructive Karl-Fischer (KF) titration.

Purpose of the Study:

  • To implement PAT using Near-Infrared Spectroscopy (NIRS) and Machine Learning (ML) for optimizing lyophilization processes.
  • To develop a rapid, non-destructive method for assessing Residual Moisture (RM) in lyophilized products.
  • To overcome the limitations of NIRS in quantifying moisture due to spectral complexity and non-linear relationships.

Main Methods:

  • Development of a PAT tool integrating NIRS with various Machine Learning (ML) models: Partial Least Squares (PLS), Support Vector Regression (SVR), XGBoost, and an ensemble PLS-SVR approach.
  • Training ML models on placebo samples and validating them on drug products for Residual Moisture (RM) assessment.
  • External validation using literature datasets with diverse formulations to confirm model robustness and adaptability.

Main Results:

  • The ensemble PLS-SVR model demonstrated improved predictive accuracy for RM across a wide range of moisture levels compared to individual models.
  • SVR excelled at lower moisture levels, while PLS was more accurate at higher RM ranges.
  • The NIRS-ML ensemble model proved robust and adaptable across different formulations, with minimal data augmentation enhancing specialization.

Conclusions:

  • The developed NIRS-ML ensemble model provides a scalable, non-destructive solution for real-time RM monitoring in lyophilized biopharmaceuticals.
  • This PAT tool supports efficient pharmaceutical manufacturing by enabling rapid, at-line assessment of a critical quality attribute.
  • The model's adaptability suggests its potential as a versatile tool for various lyophilized biopharmaceutical manufacturing pipelines.