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Related Concept Videos

Hybridoma Technology01:31

Hybridoma Technology

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Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
Hybridoma Selection
Commonly used fusion techniques — electroporation,...
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Advancing Monoclonal Antibody Manufacturing: Process Optimization, Cost Reduction Strategies, and Emerging

Ranjit Ranbhor1

  • 1Pergament & Cepeda LLC, Florham Park, NJ, 07932, USA.

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|April 14, 2025
PubMed
Summary

Monoclonal antibody (mAb) manufacturing advances, like continuous processing and advanced analytics, offer significant cost savings and efficiency gains. Optimizing these technologies is key for meeting global demand for mAb therapeutics.

Keywords:
advanced analyticsbiomanufacturingbiosimilarcontinuous processingcost reductionmachine learningprocess optimization

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Area of Science:

  • Biotechnology and Biopharmaceutical Manufacturing
  • Process Engineering and Optimization

Background:

  • Monoclonal antibody (mAb) therapeutics are critical, necessitating efficient and cost-effective manufacturing processes.
  • Current mAb production faces challenges in scalability, cost reduction, and process optimization.

Purpose of the Study:

  • To review recent advancements in monoclonal antibody (mAb) manufacturing.
  • To evaluate strategies for process optimization and cost reduction.
  • To assess the impact of emerging technologies on mAb production efficiency.

Main Methods:

  • Comprehensive literature analysis of mAb manufacturing processes.
  • Examination of traditional batch, continuous, and hybrid processing systems.
  • Evaluation of cost optimization techniques and emerging technologies like machine learning.

Main Results:

  • Continuous processing can yield up to 35% cost savings for specific production scales.
  • Hybrid facilities achieve earlier profitability (2-2.5 years sooner).
  • Advanced media optimization and analytics significantly improve mAb titers and process control.

Conclusions:

  • mAb manufacturing evolution presents opportunities for enhanced efficiency and reduced costs.
  • Scale-dependent strategies and emerging technologies are vital for optimization.
  • Future developments in continuous processing and analytics are crucial for meeting global demand.