Originally introduced in 1986, Gamimune N has continuously maintained a safety record of no documented cases of viral transmission in more than 1.9 million calculated doses. The announcement was made by Bayer Corporation in San Francisco at the joint meeting of the American Academy of Allergy, Asthma and Immunology, the American Association of Immunologists, and the Clinical Immunology Society. Gamimune N assists immunocompromised patients who lack the antibodies needed to fight bacteria and infection. Ensuring Safety from Donor to Patient Gamimune N is derived from plasma, a pale yellow fluid extracted from circulating human blood that contains many therapeutic proteins. It is collected from healthy donors, purified and separated into different biological components after its safety and quality are tested and assured.
Intensive donor screening prior to acceptance of the plasma donation is performed.
If the plasma is found to be unacceptable it is destroyed and the donor may be deferred from donating again. This step inactivates relevant and model enveloped viruses. The detergent breaks open the outer membrane, killing the virus. The final step involves a low pH incubation period which has been validated to reduce infectivity and inactivate relevant and model enveloped viruses. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.