Focused on what matters most:
Safety, quality, and efficacy
ADMA Biologics has created a robust, sustainable, reproducible, and controlled process when producing specialty plasma-derived 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.
Plasma is collected at US donor centers and tested according to FDA requirements.
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.
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.
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.