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Manufacturing Process

Focused on what matters most:
Safety, quality, and efficacy

ADMA Biologics has created a robust, sustainable, reproducible, and controlled process when producing specialty biologic products.

The IVIG/IG Production Process

Leading the way with innovative immune globulin products

ADMA Biologics is an end-to-end commercial biopharmaceutical company leading a new age of manufacturing, marketing, and commercializing specialty plasma-derived products for the prevention and treatment of infectious diseases in the immune compromised and other patients at risk for certain infections. Our devotion to these underserved populations fuels us, and our hands-on approach to production and development sets us apart.

With three FDA-licensed approved products, including ASCENIV™ (Immune Globulin Intravenous, Human – slra), BIVIGAM® (Immune Globulin Intravenous, Human), and NABI-HB® (Hepatitis B Immune Globulin, Human), ADMA’s mission is to continue to successfully develop and commercialize plasma-derived, human immune globulins targeted to specific patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations.

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1. Collect

Plasma is collected at US donor centers and tested according to FDA requirements.

2. Transport

Plasma is sent to our Boca Raton plant and pooled for further manufacturing.

3. Prepare, Pool, Precipitate

Multi-step process is initiatied where the pooled plasma is manipulated through alcohol precipitation and centrifugation steps to remove unwanted proteins and impurities.

4. Viral Inactivation

The product is then solvent detergent treated to remove any lipid envelope viruses ensuring product safety.

5. Purify

The product is then run through a series of chromatography and purification steps.

6. Final Formulation

Final formulation and bulk drug substance is completed.

7. Fill, Packaging & Visual Inspection

Bulk drug is filled into final container closure system and visually inspected to ensure high quality.

8. Testing

FDA-required potency and ADMA's specific lot release tests are performed to ensure quality, safety, potency, and purity of each batch produced.

9. Ship & Deliver

lG is delivered to treatment facilities and administered to patients.

Photo of ADMA manufacturing equipment

We offer a full suite of CDMO partnering opportunities