PR Newswire - November 2, 1995

Today's hearing of the Human Resources and Intergovernmental Affairs Subcommittee of the Government Reform and Oversight Committee was convened by U.S. Representative Christopher Shays (R-CT), chairman of the Subcommittee, to discuss efforts by the government and the blood products industry to protect the nation's blood supply from emerging infectious agents.

"Over the years, Immuno-U.S. has been a world leader among biopharmacautical companies in the development of procedures and programs targeted at reducing the risk of virus transmission in plasma products," said Dr. Philip. "Although Immuno-U.S. has not seen any confirmed transmission of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) in its virally inactivated therapeutic products, the company has put in place, at its own initiative, a series of procedures to improve the margin of safety of its products."

"These initiatives, collectively known as the 'Immuno Quality System,' are designed to provide comprehensive quality and safety improvements at every stage of Immuno's manufacturing process, from collection of source material to manufacture to viral inactivation and final product release," Dr. Philip said. "The 'Immuno Quality System,' which is in place today, exceeds FDA's quality control requirements for plasma-based derivatives."

In his testimony before the Subcommittee, Dr. Philip discussed the components of the "Immuno Quality Program." These components include: Rigorous Evaluation of All Plasma Donors and Donor Candidates

-- Plasmapheresis centers operated by Community Bio-Resources, the subsidiary of Immuno-U.S. that collects source plasma, follow stringent donor selection and screening procedures in order to secure healthy plasma donors who are free from infection and willing to become repeat donors. Screening of donors is an essential means of increasing the margin of safety for Immuno-U.S. products.

Immuno-U.S. rigorously screens its donors by asking a series of questions concerning possible high-risk behavior and past medical history and by providing a comprehensive physical exam. In addition, every unit of plasma from each donor undergoes a battery of tests, including those for the presence of HIV and hepatitis viruses and for elevations in ALT, a non- specific test for hepatitis. An individual with a positive result is permanently rejected as a donor, and any plasma collected from that person is destroyed.

Inventory Hold Program

-- In this program, instituted in 1992, all units of plasma that have been screened and found to be usable for production according to FDA guidelines are held for a period currently not less than three months. If at any time a donor is found to be reactive to viral screening or surrogate tests, Immuno-U.S. has the ability to identify all plasma units previously obtained from the donor during the inventory hold period and to remove the units for destruction.

First-Time Donor Rejection System

-- Under Immuno-U.S.'s first-time donor rejection program, introduced in 1994, the company destroys all plasma from donor applicants who do not return to make a second donation within three months. This policy was implemented because it is well known that first-time donors and donor applicants present the greatest risk to the plasma and blood supply.

Laser-Induced Fluorescence Polymerase Chain Reaction Test

-- Immuno-U.S. recently has added an additional validation step to its system. To confirm that HIV, HBV, and HCV have been excluded from plasma, each plasma pool is tested using a specialized polymerase chain reaction (PCR) system developed by Immuno. (PCR is a technique that allows for a billion-fold amplification of viral genomes that may otherwise exist at undetectable levels.)

The system, called the Laser-Induced Fluorescence PCR, is unique in that it incorporates an array of internal and external controls that allow for the highly sensitive and specific detection of genome fragments from HIV, HBV, and HCV, and allows the testing to be performed on an industrial scale. Plasma pools that are PCR reactive are destroyed.

Viral Removal and Inactivation

-- The manufacturing of Immuno-U.S. plasma products also incorporates the use of viral removal/inactivation techniques that have been validated to be highly effective against a variety of both enveloped and non-enveloped viruses. These techniques have been in use for a decade.

Final Batch PCR Testing

-- Following the manufacturing process, all batches of plasma products are again subjected to PCR testing for HIV, HBV, and HCV prior to release for distribution. As of December 1994, all Immuno products sold worldwide have been tested using PCR technology.

"The `Immuno Quality System' provides for a new level of safety in plasma products," said Glenn Pierce, M.D., Ph.D., an individual with hemophilia and an advocate for people with hemophilia. "Immuno's system appears to reduce the potential viral load in the plasma."

In his testimony, Dr. Philip emphasized that Immuno-U.S. is committed over the long term to research to develop innovative technologies to further protect against emerging viruses and other infectious agents.

The Congressional oversight hearing also focused on the blood and plasma industry response to the July 1995 Institute of Medicine (IOM) report on the HIV infection of U.S. hemophilia patients in the early 1980s. Most of the IOM report's historical information regarding the HIV infection of U.S. hemophilia patients does not relate to Immuno-U.S. because the company has never marketed a factor VIII concentrate in the United States, and did not introduce its factor IX concentrate in the U.S. until 1993.

Immuno-U.S., Inc. is a research-based biopharmaceutical company that develops, manufactures, and distributes therapeutic biologic products used in the fight against difficult-to-treat diseases, such as hemophilia, and immune disorders. Immuno also has played a leading role in research to develop a vaccine for HIV. Founded in 1980 and headquartered in Rochester, Michigan, Immuno-U.S., Inc. employs 150 people in Michigan and, through its subsidiary Community Bio-Resources, Inc., more than 600 people throughout the United States.

CONTACT: Media Information Office for Immuno-U.S., 212-880-5242/ 11:05 EST

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