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Addressing new analytical challenges in protein formulation development.

Henryk Mach1, Tudor Arvinte

  • 1Merck Research Laboratories, Merck & Co., West Point, USA. henryk.mach@merck.com

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
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Analytical methods for therapeutic proteins are advancing. New instruments and adapted techniques improve the measurement of critical parameters for bioprocess and formulation development, enhancing precision and throughput.

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Area of Science:

  • Biopharmaceutical Analysis
  • Protein Formulation Science
  • Analytical Chemistry

Background:

  • The increasing use of therapeutic proteins necessitates advanced analytical methods for drug development.
  • Existing analytical techniques often require adaptation to meet the specific demands of biopharmaceutical research.
  • There is a need for efficient and precise measurement tools throughout the drug development lifecycle.

Purpose of the Study:

  • To present novel analytical adaptations and new instruments for therapeutic protein development.
  • To enable efficient and precise measurement of critical parameters in bioprocessing and formulation.
  • To improve the characterization of protein drugs and their delivery.

Main Methods:

  • Adaptation of High-Performance Liquid Chromatography (HPLC) for viscosity measurements.
  • Utilizing atomic force microscopy (AFM) for visualizing sub-visible protein particles.
  • Employing extrinsic fluorescent dyes and flow cytometry for aggregate and particle analysis.
  • Second-derivative UV spectroscopy for monoclonal antibody concentration determination.
  • High-throughput fluorescence spectroscopy for phase separation studies.
  • Streamlined analytical ultracentrifugation and an ex vivo subcutaneous injection model.

Main Results:

  • Developed and adapted multiple analytical techniques for enhanced protein characterization.
  • Achieved efficient and precise measurement of critical parameters in protein drug development.
  • Demonstrated increased throughput and minimized sample requirements for various analyses.
  • Provided deeper insights into the nature of formulated therapeutic proteins.

Conclusions:

  • The presented analytical adaptations and new instruments significantly advance therapeutic protein development.
  • These methods offer improved precision, higher throughput, and reduced sample needs.
  • Enhanced analytical capabilities are crucial for the rigorous development of novel protein-based therapeutics.