How Is IVIG Made: Steps From Plasma to Therapy

IVIG, or Intravenous Immunoglobulin (derived from IG), is a remarkable therapy made possible by the generosity of thousands of plasma donors.

IG (immunoglobulin) therapy starts with the liquid part of the blood—plasma—collected from healthy individuals. From there, medical teams carefully extract immunoglobulins, or antibodies, which are then purified and prepared to help support or regulate the immune system. This process transforms donated plasma into a powerful therapy for people with immune deficiencies and autoimmune conditions.

Understanding how IVIG is made can bring real reassurance and peace of mind to anyone considering treatment. Every step—from plasma collection to purification and rigorous safety testing—is handled with precision and care.

It’s not just a scientific process; it’s a testament to the compassion of donors and the expertise of healthcare professionals working to deliver a safe and effective treatment.

What is IVIG?

IVIG, or Intravenous Immunoglobulin, is a therapy that delivers protective antibodies directly into the bloodstream to support the immune system. It’s used to help people with conditions where the immune system is either underactive (leading to frequent infections) or overactive (causing inflammation and damage to healthy tissues).

How IVIG Works:

Provides essential antibodies: IG contains mostly IgG antibodies, which help the body fight infections and regulate immune responses.
Supports immune function: It can supplement a weakened immune system or help calm an overactive one.
Comes from real donors: Plasma from thousands of healthy donors is pooled, purified, and processed to create IG therapy.
Administered through an IV infusion: Treatments typically take place in a specialty infusion clinic, hospital, or sometimes at home under medical supervision.

Conditions IVIG May Help Treat:

An IVIG infusion may be prescribed for a variety of immune-related conditions, including:

Primary immunodeficiencies: Such as common variable immunodeficiency (CVID), , where the body struggles to produce enough antibodies.
Autoimmune diseases: Like Guillain-Barré syndrome, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy (CIDP), where the immune system mistakenly attacks the body.
Neurological conditions: Such as multiple sclerosis (MS) and certain types of encephalitis, where inflammation affects the nervous system.
Other inflammatory and immune-mediated disorders: IVIG is sometimes used for Kawasaki disease, immune thrombocytopenia (ITP), and certain forms of lupus, like systemic lupus erythematosus.

Is IVIG Right for You?

IVIG isn’t a one-size-fits-all treatment. Healthcare providers need to carefully consider test results, medical history, and individual health needs before prescribing it. If IVIG is recommended, patients are guided through the process, including infusion expectations, IVIG preparations, and ongoing monitoring. Some people notice improvements within days, while others see gradual progress over weeks or months.

Every IVIG treatment represents the generosity of donors who make this therapy possible.

Collecting Plasma

IVIG, which is derived from IG, wouldn’t be possible without human plasma—the clear, protein-rich fluid in blood that helps carry essential nutrients, immune cells, and antibodies throughout the body. Plasma is the foundation of IG, providing the immunoglobulins that help strengthen or regulate the immune system.

Because plasma is so vital, every step of its collection and processing is carefully managed. From donor selection to rigorous safety screenings, each stage ensures that the final product is pure, effective, and safe for those who need it.

How Plasma Is Collected

Plasma donation happens at specialized centers where healthy individuals can volunteer to donate. The process includes:

Screening for eligibility: Donors go through a health check, including blood pressure readings, protein level assessments, and a review of their medical history.
Plasmapheresis: A special machine separates plasma from the donor’s blood while returning red and white blood cells, along with platelets, to their body. This allows for a faster recovery and more frequent donations.
Safe storage and transportation: After collection, plasma is frozen and stored under strict conditions until it’s ready for processing.

Why IG Therapy Requires Plasma from Many Donors

A single plasma donation doesn’t contain enough antibodies to create an effective IG treatment to be delivered through IVIG. That’s why plasma from thousands of donors is pooled together. This approach:

Creates a diverse antibody mix: Different people’s immune systems have been exposed to different pathogens, making the final IVIG product more effective at covering a broad range of infections and immune triggers.
Ensures consistency: By blending plasma from many donors, the immunoglobulin levels remain balanced, providing a reliable treatment for patients.
Keeps up with demand: Since IVIG therapy is used for conditions like primary immunodeficiencies, autoimmune diseases (such as Guillain-Barré syndrome and myasthenia gravis), and inflammatory disorders (like Kawasaki disease and immune thrombocytopenia), a steady plasma supply is essential.

How Plasma Is Tested for Safety

Patient safety is the top priority, so every plasma donation undergoes multiple rounds of testing before it’s used in an intravenous infusion. These safety measures include:

Screening for viral infections: Each batch is tested for conditions like hepatitis B and HIV. Any plasma that doesn’t meet strict safety standards is immediately discarded.
Checking for protein levels and impurities: Plasma is analyzed to ensure it contains the right concentration of immunoglobulins and is free of any irregularities.
Government and regulatory oversight: Health authorities set high standards for plasma collection and processing, often conducting surprise inspections to confirm compliance.

By the time IVIG reaches a patient, it has gone through extensive quality control to ensure it’s safe and effective.

How Plasma Becomes IVIG

Once plasma has passed all safety checks, it moves to the next stage: fractionation. This is the process of carefully separating out different proteins, most importantly, the immunoglobulins that make IG effective when it’s administered as IVIG.

Think of it like sorting ingredients in a kitchen. Scientists separate the immunoglobulins from other plasma components, many of which go on to help in other life-saving treatments.

Why This Step Matters

Consistency: Fractionation ensures every batch of IVIG meets the same high standards—no matter the source of the plasma.
Purity: It helps remove anything that isn’t needed, leaving only the proteins that support your immune system.
Efficiency: Other valuable proteins, like albumin and clotting factors, are saved and used for different medical treatments—making the most of every donation.

How It Works

To gently separate these proteins, scientists adjust things like temperature and pH. A safe solution—often including ethanol—is used to help the proteins settle into different layers. From there, the immunoglobulins are carefully collected and purified.

Every step is closely monitored and tested for safety, purity, and quality. It’s just one part of the journey, but it plays a big role in making sure your IVIG treatment is as safe, consistent, and effective as possible.

Making IVIG Safe and Effective

Before IG is ready for infusion, it goes through a carefully controlled process to make sure it’s safe, pure, and stable. From removing viruses and bacteria to fine-tuning the final formula, every step is designed to protect your health.

Purifying and Protecting the Plasma

Even though plasma donations are screened early on, extra safety steps are taken during processing. These include:

Advanced filtration: Techniques like chromatography and ultrafiltration remove unwanted proteins and particles, leaving only helpful immunoglobulins.
Virus inactivation: Methods like solvent/detergent treatments, heat (pasteurization), and virus filtration eliminate bacteria and viruses that could otherwise go undetected.
Strict testing: After purification, each batch is tested again to ensure it meets the highest standards for safety and quality.

These steps are required by regulatory agencies like the FDA, and CSP only works with trusted manufacturers who follow these strict guidelines. You can feel confident that every dose has been through multiple rounds of safety checks before it reaches you.

Formulating IVIG for Stability

Once the immunoglobulins are purified and pathogen-free, the next step is making sure they stay stable during storage and infusion. This process is called formulation.

Stabilizers: Sugars, amino acids, and proteins like albumin are added to protect the immunoglobulins from damage during transport or temperature changes.
pH balance: The pH is adjusted to make sure the solution is gentle on your veins and safe for your body.

Each formula is tested and fine-tuned until it’s just right. This helps preserve its effectiveness and shelf life, so you get the care you need, when you need it.

Why Formulas May Differ

Not all IVIG products are exactly the same. Some contain more or less sugar, salt, or stabilizers, which can affect how the infusion feels and how your body responds. That’s why your provider chooses a formula based on your unique needs—like allergies, medical history, or how quickly your infusion can be delivered.

At CSP, we make sure you get the formulation that’s right for you, always following protocols that prioritize safety, comfort, and effectiveness.

Quality Control, Packaging, and Distribution

Before you have your IG therapy, it goes through careful quality control to ensure it’s safe and effective. Every batch is thoroughly tested for contaminants, protein levels, and how well it holds up under different temperatures. If anything’s off, that batch won’t be sent out.

Packaging includes clear labeling with important details like concentration, lot number, and expiration date, helping medical providers track and manage your treatment safely. Every step of the process is carefully documented to ensure everything is in order.

To keep the product stable, IG is shipped in temperature-controlled containers, and the shipping process is closely monitored. When it arrives, pharmacies or medical teams check it again to make sure it’s still in top condition.

Tests are also done to confirm that the immunoglobulins are working properly, ensuring they’ll bind to the right pathogens and remain stable. If anything doesn’t pass the test, the batch is set aside for further review.

Once everything is cleared, IG is packaged and distributed with extra care. This ensures it stays safe, effective, and ready for your IVIG treatment when you need it.

A Collaborative Effort for Better Health

IG therapy is the result of a dedicated team effort—from plasma donors to scientists, lab technicians, and healthcare providers—all working to create a therapy that helps people with immune deficiencies, autoimmune conditions, and neurological issues. Each step, from purification to packaging, ensures the final product is safe and effective.

At CSP, we guide patients through every stage of IVIG treatment, offering support and answering questions to help you feel confident and cared for. If you’re considering IVIG, we’re here to provide expert guidance and ensure you have the support you need.

Frequently Asked Questions:

How much blood does it take to make IG?

It takes plasma from about 1,000 to 10,000 healthy donors to produce a single batch of IG, depending on the manufacturer.

How do we make IVIG?

IVIG is derived from IG, which is made by collecting plasma from healthy donors. The plasma is then processed to isolate and concentrate immunoglobulins. After that, it goes through purification, testing, and packaging to ensure safety and effectiveness.

How many donors does it take to make IVIG?

Typically, thousands of donors are needed to provide enough plasma for a batch of IVIG, ensuring a diverse and effective range of antibodies.

What are the ingredients in IVIG?

IVIG primarily contains immunoglobulins, especially IgG antibodies, which come from pooled plasma donations. It may also include stabilizing agents to maintain the product’s stability during storage and use.

References:

Shehata N. Patient education: Intravenous immune globulin (IVIG) (Beyond the Basics). UpToDate, 2025. https://www.uptodate.com/contents/intravenous-immune-globulin-ivig-beyond-the-basics/print
Afonso AFB, Pires João CM. The Production Processes and Biological Effects of Intravenous Immunoglobulin. Biomolecules. 2016 Mar 9;6(1):15. https://pmc.ncbi.nlm.nih.gov/articles/PMC4808809/
B. Arumugham V, Rayi A. Intravenous Immunoglobulin (IVIG). 2023 Jul. https://www.ncbi.nlm.nih.gov/books/NBK554446/
Intravenous Immunoglobulin (IVIG). American College of Rheumatology (ACR). 2025 Mar. https://rheumatology.org/patients/intravenous-immunoglobulin-ivig
Plasma. Cleveland Clinic. 2025 Mar. https://my.clevelandclinic.org/health/body/22865-plasma

Legal Disclaimer: The content provided on this blog is for informational purposes only and is not intended to serve as medical advice, diagnosis, or treatment. While we make every effort to provide accurate and up-to-date information regarding immunoglobulin (IVIG) therapy, the details shared here are based on general knowledge and should not be considered a substitute for professional medical consultation or advice.

Immunoglobulin therapy is a specialized medical treatment that should only be prescribed and administered by a licensed healthcare provider. Individuals considering or undergoing immunoglobulin therapy should consult with their physician or healthcare provider to discuss their specific medical needs, potential risks, benefits, and any alternatives. Only a qualified healthcare professional can assess your individual health conditions and determine the most appropriate treatment plan.

By accessing this blog, you agree to hold harmless the author, publisher, and any associated parties from any claims, liabilities, or damages arising from the use or interpretation of this content.

How Is IVIG Made?