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Downstream process development strategies for effective bioprocesses: Trends, progress, and combinatorial approaches.

Pascal Baumann1, Jürgen Hubbuch1

  • 1Biomolecular Separation Engineering Karlsruhe Institute of Technology (KIT) Karlsruhe Germany.

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Summary

Biopharmaceutical manufacturing is shifting to precision medicine, requiring faster purification processes for new antibody molecules. This review explores effective strategies, combining conventional and modern methods for efficient bioprocess development.

Keywords:
Combinatorial approachHigh‐throughput technologiesModelingProcess developmentProtein purification

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Development
  • Precision Medicine

Background:

  • The biopharmaceutical industry is transitioning towards precision medicine, emphasizing customized and patient-oriented therapies.
  • Production processes are expanding to include a diverse portfolio of molecules beyond traditional antibodies.
  • This shift necessitates agile and dedicated purification process development strategies.

Purpose of the Study:

  • To review effective strategies for biopharmaceutical purification process development applicable to new antibody generations.
  • To compare conventional heuristic and high-throughput methods with advanced modeling techniques.
  • To present combinatorial approaches as future directions for efficient bioprocess development.

Main Methods:

  • Review of conventional purification process development strategies, including heuristics and high-throughput screening.
  • Evaluation of modern technologies such as multivariate calibration and mechanistic modeling.
  • Exploration of combinatorial approaches integrating diverse methodologies.

Main Results:

  • Conventional and modern methods provide a foundation for rapid process development.
  • Correlated combinations of these approaches unlock their full potential for complex molecules.
  • The study identifies promising combinatorial strategies for future biopharmaceutical manufacturing.

Conclusions:

  • Integrated strategies combining conventional and modern techniques are crucial for fast and effective purification process development.
  • These approaches are essential for the next generation of biopharmaceuticals, including new antibody formats.
  • Combinatorial strategies represent a key future direction for the biopharmaceutical industry.