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Related Experiment Videos

A 21st century HPLC workflow for process R&D.

Brent D Karcher1, Merrill L Davies, Edward J Delaney

  • 1Pharmaceutical Research Institute, Bristol-Myers Squibb, 1 Squibb Drive, MS NB 50-2-1, New Brunswick, NJ 08903, USA.

Clinics in Laboratory Medicine
|April 10, 2007
PubMed
Summary
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A new high-performance liquid chromatography (HPLC) workflow automates impurity screening using a software-hardware platform. This system rigorously assesses samples and develops improved HPLC methods for process development.

Area of Science:

  • Analytical Chemistry
  • Process Development
  • Chromatography

Background:

  • Traditional high-performance liquid chromatography (HPLC) methods can be time-consuming for process development.
  • Identifying and quantifying impurities is critical for ensuring product quality and safety.
  • A need exists for automated and systematic approaches to impurity profiling in complex samples.

Purpose of the Study:

  • To develop a unique HPLC workflow optimized for the demands of process development.
  • To create an automated software-hardware platform for systematic sample screening.
  • To demonstrate the platform's utility in assessing sample complexity and developing new HPLC methods.

Main Methods:

  • Assembled a novel HPLC workflow platform using commercial hardware and custom/commercial software.

Related Experiment Videos

  • Implemented an automated system for systematically screening samples across a matrix of columns and eluents.
  • Utilized the platform to challenge existing methods and develop new analytical strategies.

    • Main Results:

    • Successfully developed and implemented a unique HPLC workflow for process development.
    • The automated platform efficiently screens samples to identify and characterize impurities.
    • Demonstrated the platform's effectiveness through three real-world case studies.

    Conclusions:

    • The developed HPLC workflow and platform provide a robust solution for impurity analysis in process development.
    • This automated approach enables rigorous assessment of sample complexity and accelerates method development.
    • The system facilitates the creation of new and improved HPLC methods for enhanced analytical performance.