Bayer Biological Products (BP) has received German regulatory approval for its drug Gamunex and U.S. FDA approval for in-house nucleic acid testing (NAT) of HIV in plasma donations.

Gamunex, which is manufactured in Bayer’s facility in Clayton, NC, was approved by the Paul Ehrlich Institute, Germany’s regulatory authority for biological products. The drug is a new, advanced immunoglobulin (IGIV) product that builds on Bayer BP’s Polyglobin, an IGIV brand in Germany.

Each vial of Gamunex contains antibodies purified from the donated blood plasma of thousands of people and can be a lifesaving therapy for individuals with compromised, missing, or malfunctioning immune systems. In those cases, Bayer says the broad spectrum of antibodies in Gamunex acts as an immune system replacement and provides a shield of protection against infection.

Bayer says approval of the drug in Germany represents another “major milestone” in the phased global launch of Gamunex and is a first step in providing the newest IGIV treatment to patients in Europe. The drug already has been introduced successfully in the United States and Canada following regulatory approval in both countries in August of last year.

“This approval in Germany is a significant step forward as we begin to realize the tremendous potential for Gamunex in the worldwide IGIV market,” said Joseph Akers, president of Bayer BP. “As part of our ongoing commitment, we built a state-of-the-art manufacturing facility to house the revolutionary new production process for Gamunex,” referring to the Clayton facility.

In addition, Akers said Bayer BP is already investing in the next phase of development with clinical studies in neurological disorders, including multiple sclerosis and chronic inflammatory polyneuropathy.

Bayer BP, the RTP-based division of Bayer HealthCare of Germany, also has learned it received U.S. FDA approval for in-house NAT of HIV in plasma donations. Based on this approval, Bayer BP says it becomes the first plasma “fractionator” to perform in-house screening for HIV using an FDA-licensed test. The company’s plasma business is also located in Clayton, but is up for sale.

The approved Bayer BP protocol allows for identification and detection of specific HIV-contaminated donations so infected donors can be notified, counseled for follow-up treatment, and prevented from future donations. Further, by conducting this testing in-house, Bayer BP says it can more directly ensure the integrity and efficiency of the testing process and the resulting safety of its plasma products.

“Approval of our plasma screening protocol is a significant step forward in advancing the safety of biological products,” said Akers. “Much like our industry-leading work in the area of pathogenic prions, this is another first for Bayer BP, reflecting the outstanding work of our pathogen safety team. More importantly, it provides continuing excellent news for our patients who rely on us to provide the safest possible products.”

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