Monoclonal Antibodies

What are monoclonal antibodies?

Monoclonal antibodies (also called moAbs or mAbs) are proteins made in laboratories that act like proteins called antibodies in our bodies. Antibodies are parts of your immune system. They seek out the antigens (foreign materials) and stick to them in order to destroy them. Laboratory-made monoclonal antibodies help stimulate your own immune system.

The word “monoclonal” refers to the fact that the antibodies created in the laboratory are clones. They are exact copies of one antibody. The generic names of the products often include the letters “mab” at the end of the name.

What is the difference between monoclonal antibodies and polyclonal antibodies?

The difference between the two types of antibodies is in the names. “Mono” refers to one and “poly” refers to many. Monoclonal antibodies are clones of just one antibody, and they bind to one antigen only. Polyclonal antibodies come from several different types of immune cells and will bind to more than one antigen.

How are monoclonal antibodies used?

Monoclonal antibodies are used for diagnosis, disease treatment and research. They’re used:

• As probes to identify materials in laboratories or for use in home-testing kits like those for pregnancy or ovulation.
• To type tissue and blood for use in transplants.
• For diagnosis.
• For disease treatment.

What types of diseases do monoclonal antibodies treat?

Monoclonal antibodies have been used to treat the following conditions:

• Cancer.
• Organ transplant rejection.
• Inflammatory and autoimmune disorders, including allergies.
• Infections, including COVID-19.
• Osteoporosis.
• Eye conditions.
• Migraines.
• High cholesterol.
• Nervous system disorders.

The number of U.S. Food and Drug Administration (FDA) approvals of monoclonal antibody therapies has been rising since the first monoclonal antibody drug for humans was approved in 1986.

Is treatment with monoclonal antibodies common?

Monoclonal antibody therapy is becoming more common, as therapy continues to rise.

How are monoclonal antibodies used during a procedure?

In most cases, monoclonal antibodies are given mostly as intravenous (IV) solution injected right into your vein (sometimes referred to as an infusion). They’re often given in an infusion center where there are several people getting treatment at one time.

If you’re getting a treatment for the first time, you’ll probably need to bring someone with you to learn about the procedure and what to expect. During your first treatment, healthcare providers will be looking for any type of serious allergic reaction.

In a few cases, your healthcare provider might also prescribe a monoclonal antibody that’s given subcutaneously (injected under the skin). You’ll be taught how to give yourself a shot, often in your abdomen or upper thigh.

Monoclonal antibodies can be:

• Given as therapy by themselves. These are known as naked monoclonal antibodies.
• Made into radioactive particles and given as therapy along with another drug. These are known as conjugated, tagged, loaded or labeled monoclonal antibodies.
• Modified to attach to and so, then attack two specific antigens at the same time. These are known as bispecific monoclonal antibodies.

What are the advantages of using monoclonal antibodies?

One key advantage of using monoclonal antibodies is they’ve been used to make drugs that have been more successful at treating certain diseases, such as some cancers.

Another advantage of using monoclonal antibodies as a treatment is that they’re more precise than other treatments. This improves the effectiveness and can reduce some side effects.

Monoclonal antibody quality is standard for all production batches, which is important for use as therapy, as well as for diagnostics.

It’s now possible to make monoclonal antibodies in large quantities.

What are the risks or complications of using monoclonal antibodies?

Infusion reactions are common, and occur during or shortly after monoclonal antibody treatment. These occur when your body has a strong immune response to the monoclonal antibody treatment. Common signs of infusion reaction are rash, fever, rigors/chills, shortness of breath, sweating, changes in blood pressure and increased heart rate. Slowing down the infusion or decreasing the dose can help limit such reactions.

There’re more serious but less common risks linked to unwanted immune system reactions, such as acute anaphylaxis, cytokine release syndrome (CRS) and serum sickness.

Acute anaphylaxis is a massive allergic reaction that can be life-threatening. Serum sickness happens when your body’s immune system attacks the antiserum, or a blood product containing the proteins that your healthcare team is using to try to help you. CRS is also called cytokine storm and can lead to organ damage.

Some of the risks related to monoclonal antibody therapy are specific to the type of condition being treated. For instance, tumor lysis syndrome is a condition that’s usually caused by cancer treatment that can result in kidney failure.

What is the recovery time if I take monoclonal antibodies?

Infusion times can vary. As an example, though, monoclonal antibody treatment for COVID-19 under Emergency Use Authorization took about an hour for infusion and then another hour or so to watch for any reaction to the infusion.

Your healthcare provider may recommend that you bring an adult family member or friend the first time that you have an infusion. This might not be necessary for further treatments if you don’t have a bad reaction. You may be ready to return to work or school if you feel well after the treatment. These are questions for your healthcare provider. The answers are likely to depend on what you’re being treated for and your overall health.

Should I talk to my doctor about treatment?

If you’ve had a monoclonal antibody treatment, and you’re having an expected reaction, call your healthcare provider or go to an emergency room.

If you’re diagnosed with a condition that monoclonal antibodies treat, talk with your healthcare provider about whether or not this type of therapy may be suitable for you.

A note from Cleveland Clinic

Antibodies are part of your immune system. Monoclonal antibodies are clones of your body’s antibodies that are made in a laboratory, meant to stimulate your immune system. Monoclonal antibodies as therapies are more targeted than some other types of treatments and have been more successful at treating some types of diseases, including some cancers. Your healthcare provider may prescribe monoclonal antibodies, depending on what you’re being treated for and your overall health.