IUBio Biosequences .. Software .. Molbio soft .. Network News .. FTP

ALPHA ANNOUNCES NEW PROCEDURES TO ENHANCE PLASMA PRODUCT SAFETY

John Gross ir000069 at interramp.com
Thu Mar 21 14:43:26 EST 1996


Thought this would be of interest to the group.
________________________________________________________________________


LOS ANGELES, March 19  -- Alpha Therapeutic Corporation (Alpha) announced
that starting today, new procedures will be implemented, as added internal
release criteria for plasma products manufactured by Alpha in order to
provide further product safety assurance. Samples of all product lots will
now be tested in their final container for the presence of genomic
sequences of Human Immunodeficiency Viruses 1 and 2, Hepatitis A, B, and C
Viruses using a highly specific and sensitive generation of Polymerase
Chain Reaction (PCR) testing. Serological testing for infectious disease
markers will be performed on plasma pools for fractionation. Only lots
with negative tests will be released. Alpha has voluntarily initiated
these extended product testing procedures. The new procedures are
effective immediately for all Alpha manufactured products sold in the
United States while products sold in the rest of the world will follow
shortly.

OVERVIEW OF ALPHA EXTENDED TESTING PROCEDURES OF PRODUCTS 

Individual Plasma Plasma Pool Final Product
Donation (Alpha Extended Testing)

HIV-1/2  EIA Antibody Test EIA Antibody Test PCR RNA Test
(FDA Required)

Hepatitis C ELISA Antibody Test ELISA Antibody Test PCR RNA Test 
(FDA Recommended)

Hepatitis B HBs Antigen Test  HBs Antigen Test  PCR DNA Test
(FDA Required)

Hepatitis A ALT Test PCR RNA Test
(A Surrogate Marker)

By isolating a viral nucleic acid and amplifying it over one million
times, scientists are now able to provide information about the presence
or absence of virus particles that may escape detection using standard
testing procedures. 

The new viral detection methods announced by Alpha extend the safety
provided by current antibody detection assays. It may take as long as 100
days or more for an individual infected with a virus to develop laboratory
detectable antibodies. By incorporating PCR testing, Alpha hopes to detect
the presence of virus in any product purified from blood plasma, even if
an infected donor has not yet developed antibodies. Alpha is using PCR
testing to ensure the maximum safety of its current plasma products. 

"A negative PCR test result is strong evidence of the absence of virus,"
Said Dr. Andrew Conrad, Ph.D., Director of Clinical Trials, and Dr. Peter
Schmid, Chief Scientist at National Genetics Institute, a Los
Angeles-based commercial laboratory specializing in highly sensitive PCR
testing.

"National Genetics Institute has an excellent record for PCR testing
sensitivity, specificity and reliability. We selected National Genetics
Institute in order to add another key element to our commitment to the
safety of products supplied to patients," commented H. Edward Matveld,
President and Chief Executive Officer of Alpha. "Alpha believes that the
combination of serological testing and PCR tests, coupled with our
manufacturing processes for viral reduction and viral inactivation,
represent the best possible use of the technologies available today,"
concluded Mr. Matveld. 

Alpha is currently investigating the possible transmission of Hepatitis A,
a self-limiting liver infection, in five hemophilia patients who infused
Alpha's coagulation products. While scientific discussion continues over
possible causes, Alpha has chosen to extend currently used screening
procedures and to employ the very sensitive PCR testing to address the
issue of product safety immediately. According to Mr. Matveld, "These
important steps are a part of Alpha's continuing pursuit to enhance plasma
product safety." 

Alpha Therapeutic Corporation is a world leader in the development,
manufacturing and marketing of plasma-derived biopharmaceutical products.
Headquartered in Los Angeles, California, Alpha was established in 1978 by
the Green Cross Corporation of Osaka, Japan. Alpha Therapeutic places the
highest priority on product quality and safety. The current business
development strategy is focused on capital investment in new manufacturing
and quality control facilities, in-licensing and alliances for the
development, marketing of new pharmaceutical products as well as global
market expansion through subsidiaries and affiliates in Europe, Asia and
South America. 

                   -0-   3/19/96

CONTACT: John Gross, Director, Professional Services, of Alpha Therapeutic
Corporation, 213-227-7691



More information about the Virology mailing list

Send comments to us at biosci-help [At] net.bio.net