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Related Concept Videos

Hybridoma Technology01:31

Hybridoma Technology

16.3K
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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Antibody Structure and Classes01:25

Antibody Structure and Classes

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Antibodies, also known as immunoglobulins, are produced by B cells in response to foreign substances, such as bacteria and viruses. These proteins are critical for recognizing and neutralizing these substances, protecting the body from potential harm.
The basic structure of an antibody consists of four protein chains: two identical heavy chains and two identical light chains. These chains are held together by disulfide bonds and other non-covalent interactions, forming a Y-shaped structure.
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Generation of Murine Monoclonal Antibodies by Hybridoma Technology
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The Different Colors of mAbs in Solution.

Alexandre Ambrogelly1

  • 1Pharmaceutical and Biologics Operations, Gilead Sciences, 4010 Ocean Ranch Blvd, Oceanside, CA 92056, USA.

Antibodies (Basel, Switzerland)
|June 2, 2021
PubMed
Summary

The color of therapeutic monoclonal antibody solutions is a critical quality attribute. This review covers analytical methods for assessing protein solution color and identifies variants/impurities causing discoloration.

Keywords:
Advanced Glycation End products (AGE)European Pharmacopoeia EP2.2.2N-formylkynurenineUnited States Pharmacopeia USP, USPcolor testingkynureninemonoclonal antibodytristimulus colorimetrytryptophan oxidation

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Area of Science:

  • Biopharmaceutical analysis
  • Protein chemistry

Background:

  • Therapeutic monoclonal antibody (mAb) solution color is a critical quality attribute.
  • Color consistency is assessed at release and during stability studies against predefined criteria.
  • Color can be measured via visual inspection or quantitative methods according to compendia.

Purpose of the Study:

  • To review analytical methodologies for determining protein solution color.
  • To provide an overview of protein variants and impurities that cause discoloration in recombinant therapeutic proteins.

Main Methods:

  • Review of analytical techniques for color assessment.
  • Identification of known color-contributing protein variants and impurities.

Main Results:

  • Various analytical methods exist for color determination, including visual and quantitative approaches.
  • Specific protein variants and impurities are known to impact the color of therapeutic protein solutions.

Conclusions:

  • Accurate color assessment is crucial for therapeutic protein quality control.
  • Understanding the sources of discoloration aids in maintaining product consistency and safety.