Monoclonal Antibody Treatment Solutions for COVID–19

The History of Antibodies
The origins of immune defensive antibodies were discovered by Emil von Behring and Shibasabura Kitasato in 1890. They published their findings demonstrating the transfer of serum from animals immunized against diphtheria into the bloodstream of infected animals. They noted that the antibodies contained within the serum was able to cure the infected animals. Behring was awarded the Nobel Prize in 1901. [1]

The Function of Natural Antibodies
The immune system harbors a complex system of molecular activity that is designed to detect and destroy harmful substances. When the body detects a threat in the way of a virus, bacteria, or fungus—the body produces antibodies that attach to a part of the invader (usually a protein on its surface), which is called an antigen. Once an antibody binds to an antigen, it then enlists the help of other immune system protective cells to attack and destroy the foreign invaders. [2]

Monoclonal antibodies
Monoclonal antibodies are laboratory-produced molecules that act in the same way natural antibodies work. They help boost the body's own natural defensive activity within immune system. A monoclonal antibody is created by exposing a white blood cell to a particular viral protein, which is then cloned to mass-produce antibodies to target that virus. [2]

Monoclonal antibodies continue to play a vital role in developing treatment options to fight many chronic health conditions and diseases such as cancer. Researchers are working hard to decipher the complex molecular interactions so they can apply this knowledge to counteract disease. Prior to COVID-19, monoclonal antibodies were developed to treat several viral infections, such as Ebola and rabies. [2]

How Do Monoclonal Antibodies Work Against COVID-19?

Monoclonal antibodies for COVID-19 work by blocking the molecules that attack the immune system. They also demonstrate a neutralizing effect on the COVID-19 virus. Monoclonal antibodies prevent the COVID-19's ability to replicate. They also work by clearing already infected cells, thereby slowing the rate of infection and severity. [2]

 

How Many COVID-19 Treatments Are Available in the US Currently?
The FDA has approved many monoclonal antibodies treatment products for emergency use and many more authorizations are on the way. In the United States, there are three anti-SARS-CoV-2 monoclonal antibody treatments with FDA Emergency Use Authorization (EUA) for the treatment of COVID-19: bamlanivimab plus etesevimab, casirivimab plus imdevimab,, and sotrovimab. [2]

How Effective Are Monoclonal Antibody Treatments?
Monoclonal antibodies can be effective at decreasing hospitalization rates and progression to severe disease and death for patients with mild to moderate COVID-19. In addition, monoclonal antibody treatments are shown to improve patient outcomes, especially in those with weakened or compromised immunity. [2]

Challenges Associated with Monoclonal Antibody Treatment Options

The pandemic fueled the response to repurpose existing drugs, although there are still some questions surrounding efficacy and quality. As more is learned about the virology and clinical presentation of COVID-19, we can expect improved offerings. [3]

Distribution and equitable access to receive the monoclonal antibody COVID-19 treatments represent another facet of challenges. To date, the distribution has resumed, however, dispersing the treatments to vulnerable populations and outlying clinics remains problematic.

Determining Eligibility to Receive Monoclonal Antibody Treatment for COVID-19
Monoclonal antibody treatment for COVID-19 is different from the COVID-19 vaccine. The vaccine triggers your body’s natural immune response; however, it may take a while to produce enough antibodies to combat the virus.

For those currently infected with the COVID-19 virus, the monoclonal antibody treatment can assist in fighting off the virus and lessen its severity.

Assessing patient risk factors is a key component in determining eligibility. Those who are at high-risk and have been in close contact with a person testing positive are urged to seek an infusion center for monoclonal antibody treatment.

High-Risk Factors for COVID-19 include:


·       65 years of age or older

·       Overweight (body mass index over 25)

·       Pregnancy

·       Chronic kidney disease

·       Diabetes (Type 1 and Type 2)

·       Weakened immune system

·       Currently receiving immunosuppressive treatment

·       Cardiovascular disease/hypertension

·       Chronic lung disease

·       Sickle cell disease

·       Neurodevelopmental disorders

·       Medical-related technological dependence

 

How is the Monoclonal Antibody COVID-19 Treatment Administered?

Monoclonal antibody therapy is given through intravenous (IV) infusion. These infusions are given in one of our outpatient infusion centers and require about an hour to administer, followed by an hour of observation and monitoring.

 Medical Refrigeration Storage Requirements for the Monoclonal Antibody COVID-19 Treatments

Casirivimab/Imdevimab Injection

Store intact vials at 2 - 8°C (36 - 46°F, refrigerator temperature); do not freeze, shake, or expose to direct light.

Diluted infusions are stable for up to: • 36 hours (about 1 and a half days) at 2 – 8°C (36-46F, vaccine refrigerator temperature); allow to warm to room temperature for 30 minutes before infusing. • 4 hours at 20 - 25°C (68 - 77°F, room temperature)

Bamlanivimab (and etesevimab)

Store intact vials Intact vials at 2 - 8°C (36 - 460F, vaccine refrigerator temperature); do not freeze, shake, or expose to direct light

Diluted infusions are stable for up to • 24 hours at 2 - 8°C (36-46°F, vaccine refrigerator temperature); allow to warm to room temperature for 30 minutes before infusing. • 7 hours at 20 - 25°C (68 - 77°F, room temperature) including infusion time.

Sotrovimab

Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in original carton. Do not freeze or shake. Protect from light.


Medical Grade Refrigeration Solutions for Monoclonal Antibody COVID-19 Treatments

K2 Scientific offers a wide variety of medical grade refrigeration and freezers specifically engineered for reliable vaccine storage – but at significantly lower costs. Many of our units are energy star rated and are compliant with FDA regulations. K2 focuses on quality, reliability and customer service. We back all lab refrigerators and freezers with a 2-year full-replacement warranty. We offer an additional 5-year compressor warranty on our High-Performance medical refrigerators and freezers.

The K2 Team is always ready to assist you with any questions regarding selection, availability, and delivery. We value our scientific partnerships and invite you to learn more.

 

 References:

1. Behring, E., and Kitasato, S. (1890). Uber das Zustandekommen Der Diphtherie- Immunitat Und der Tetanus-Immunitat Bei Thieren. Dtsch Med Wochenschr 49, 1113–1114.

2. https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808

3. https://www.frontiersin.org/articles/10.3389/fphar.2020.588654/full

4. "COVID Antibody Testing at Mahaffey Theater" by CityofStPete is licensed under CC BY-ND 2.0