Are Monoclonal Antibodies Humanized In A Laboratory?

Monoclonal antibodies have been receiving much attention as a Covid-19 treatment. But many have questions about what humanization means. How are monoclonal antibodies humanized? Are they the right treatment option for you? Keep reading to learn more!

What does it mean to humanize monoclonal antibodies?

Monoclonal antibodies are synthetic proteins that function like antibodies that are naturally produced by the body. The names of the different types of antibodies indicate how they were made:

• Human: These proteins are created from fully human cells. Treatment names end in –umab.
• Murine: Murine proteins are made with mouse proteins. Treatment names end in –omab.
• Chimeric: These are a combination of mouse and human proteins. Treatment names end in –ximab.
• Humanized: These proteins are made by attaching small parts of mouse proteins to human proteins. Names of treatments end in –zumab.

Proteins are formed by chains of amino acids. To create monoclonal IV treatments, antibodies are harvested from people or animals and then processed and replicated in a laboratory. During processing, experts adjust the DNA of the proteins being produced to make sure they target the desired antigen, and also don’t trigger any unwanted responses by the immune system.

When animal cells are being used, this involves replacing most of the animal portions of antibody amino acids with human amino acid chains. This process is how monoclonal antibodies are humanized.

What kinds of conditions can monoclonal antibodies treat?

Monoclonal antibody treatments are not a new development. Monoclonal antibodies have been developed to treat or prevent a variety of conditions for decades, including:

• Rheumatoid arthritis, psoriatic arthritis, and Crohn’s disease
• Asthma, psoriasis, or Respiratory Syncytial Virus (RSV)
• Cancers like leukemia, lymphoma, and breast cancer

What else should I know about Covid-19 monoclonal antibodies?

Covid-19 monoclonal antibodies are not a substitute for vaccination. They are available by prescription only after a known exposure or positive Covid-19 test. Additionally, treatment is only available to those at high risk of hospitalization from Covid-19 who are not hospitalized or receiving oxygen.

Treatments must be administered within 10 days of the development of symptoms to experience benefits; once the immune system’s inflammatory response has been triggered, monoclonal IV therapy will have no effect.

There are currently two monoclonal antibody therapies that have Emergency Use Authorization (EUA) from the FDA:

• Sotrovimab is produced by GlaxoSmithKline and Vir. A study of patients who received this treatment showed an 85% reduction in hospitalization or fatality when compared to those who did not receive treatment.
• Genentech is the manufacturer of Actemra (tocilizumab). Unlike the other monoclonal antibody therapies for Covid-19, Actemra is intended for treatment of those already hospitalized with Covid-19. It already has full FDA approval for treatment of rheumatoid arthritis, and works by reducing inflammatory response, which has been linked to severe Covid-19 progression.

In addition to these, there were two treatments which were available for use under the FDA’s EUA until February 2022:

• Eli Lilly and Company created the monotherapy bamlanivimab and the combination therapy containing bamlanivimab and etesevimab. These therapies were most effective against earlier Covid-19 strains.
• REGEN-COV2 was made by Regeneron. It was a combination treatment containing casirivimab and imdevimab. This monoclonal antibody therapy reduced hospitalization by 80% in a recent study.

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