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A Process Analytical Technology (PAT) approach to control a new API manufacturing process: development, validation

Cédric Schaefer1, David Clicq2, Clémence Lecomte3

  • 1UCB Pharma, Analytical Development Chemicals, Avenue de l'Industrie, 1420 Braine-l'Alleud, Belgium; Institut des Sciences Moléculaires de Marseille, CNRS, UMR 7313, École Centrale Marseille, Aix Marseille Université, Avenue Escadrille Normandie-Niemen, Case A62, 13397 Marseille cedex 20, France.

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Summary
This summary is machine-generated.

A new near-infrared (NIR) spectroscopy method, developed using Quality-by-Design (QbD) principles, enables real-time control of active pharmaceutical ingredient (API) crystallization. This Process Analytical Technology (PAT) tool precisely monitors API and residual solvent levels, ensuring product quality.

Keywords:
API crystallizationIn-process control (IPC)Method validationNear infrared spectroscopyProcess Analytical Technology (PAT)Quality-by-Design (QbD)

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Area of Science:

  • Pharmaceutical Manufacturing
  • Analytical Chemistry
  • Process Engineering

Background:

  • Pharmaceutical industry adoption of Process Analytical Technology (PAT) and Quality-by-Design (QbD) is driven by regulatory agencies.
  • PAT and QbD aim to build quality into products through scientific understanding and risk management.
  • Accurate control of active pharmaceutical ingredient (API) crystallization requires precise monitoring of API and residual solvent content.

Purpose of the Study:

  • To develop and validate a near-infrared (NIR) spectroscopy method as a PAT tool for on-line monitoring of API crystallization.
  • To ensure the NIR method is fit for its intended use by applying Quality-by-Design (QbD) principles.
  • To precisely determine API and residual solvent content during the crystallization step for optimal seeding.

Main Methods:

  • Development and validation of an analytical method using near-infrared (NIR) spectroscopy.
  • Application of Quality-by-Design (QbD) principles for method development and validation.
  • Optimization of Partial Least Squares (PLS) models using chemometrics and validation according to ICH Q2(R1) guideline with accuracy profile approach.

Main Results:

  • A validated NIR method was established for on-line monitoring of API crystallization.
  • The method accurately quantifies API (9.0-12.0% w/w) and residual methanol (0.18-1.50% w/w).
  • Real-time process monitoring demonstrated the method's suitability for industrial application.

Conclusions:

  • The developed NIR-based PAT tool enables automatic, real-time control of the final API crystallization step.
  • Implementation of this in-process control (IPC) method ensures a predefined API quality level.
  • Expected benefits include reduced process time and elimination of difficult sampling and off-line analyses.