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Related Concept Videos

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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.
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Commonly used fusion techniques — electroporation,...
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Related Experiment Video

Updated: Jul 12, 2025

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
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Stability Comparison Between Microglassification and Lyophilization Using a Monoclonal Antibody.

Karthik Balakrishna Chandrababu1, Aadithya Kannan2, John R Savage1

  • 1Lindy Biosciences, 627 Davis Dr. #400 Morrisville, North Carolina 27560, United States.

Journal of Pharmaceutical Sciences
|October 20, 2023
PubMed
Summary
This summary is machine-generated.

Microglassification™ offers a novel method for creating stable solid-state biologics, like monoclonal antibodies, by avoiding heat stress during dehydration. This new technique demonstrates comparable protein stability to traditional lyophilization.

Keywords:
Antibody drugChemical stabilityDehydration, LyophilizationMicroparticle(s)Monoclonal antibody(s)Protein formulationProtein(s)Solid-state stability

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Area of Science:

  • Biopharmaceutical formulation
  • Protein stabilization technologies
  • Solid-state drug delivery

Background:

  • Lyophilization and spray drying are common but challenging for biologics.
  • Challenges include protein thermal stability, cost, and manufacturing scalability.
  • Novel dehydration methods are needed for improved solid-state biologic formulations.

Purpose of the Study:

  • To evaluate Microglassification™ as a novel dehydration technology for biologics.
  • To compare the molecular stability of monoclonal antibody formulations produced by Microglassification™ versus lyophilization.
  • To assess the viability of Microglassification™ for producing stable solid-state monoclonal antibody formulations.

Main Methods:

  • Microglassification™ uses solvent extraction for rapid dehydration at ambient temperatures.
  • Lyophilization and Microglassification™ were used to process a monoclonal antibody formulation.
  • Formulations were subjected to stability testing at 40 °C for 3 months and 25 °C for 6 months.

Main Results:

  • Both lyophilization and Microglassification™ yielded chemically stable monoclonal antibody formulations.
  • No significant differences were observed in percent monomer, charge variants, or antigen binding between the two methods.
  • Microglassification™ produced spherical, dense, and chemically stable microparticles.

Conclusions:

  • Microglassification™ is a viable alternative to lyophilization for producing stable solid-state monoclonal antibody formulations.
  • The ambient temperature processing of Microglassification™ mitigates thermal stress on biologics.
  • This technology shows promise for improving the manufacturing of solid-state biologics.