IMPACTS OF BIOTECHNOLOGY ON BIOMEDICAL SCIENCES 89

 The third recombinant therapeutic product to be approved by the FDA
for distribution and marketing in this country is alpha interferon. Devel-
oped by Genentech/Hoffman La Roche and Biogen, alpha interferon is
also being produced in bacteria. The recombinant product appears to offer
protection against cold viruses. It is anticipated that it will prove useful
against a variety of cancers and viral diseases. In April, 1986, FDA ap-
proval was granted to Schering-Plough to market alpha interferon for
treatment of hairy cell leukemia, multiple myeloma, non-Hodgkin's lym-
phoma and Kaposi's sarcoma.
 Another interferon, gamma interferon, was also developed by Genen-
tech. The recombinant gamma interferon can be produced in bacteria,
and it is now in Phase III Clinical Trials by Biogen. Other companies
involved in its production are Amgen and Schering-Plough. The recombi-
nant product activates macrophages and it is expected to have important
antitumor and antiviral properties.
 Another lymphokine receiving much attention is recombinant inter-
leukin II. This product was developed by Cetus, and several other com-
panies, including Immunex, Biogen and Collaborative Research, which
are also involved in its production. It is hoped that interleukin II will prove
useful in treating immune deficiencies resulting from cancer, chemother-
apy, childhood diseases and aging. A Japanese firm, the Takeda Chemical
Company, recently announced the large scale production of interleukin II
in bacteria. So much recombinant product is manufactured in the bacte-
rium that large inclusion bodies of the protein form. It is indeed remark-
able that scarce proteins such as interleukin II can now be produced in
such quantities to allow physical studies of the molecule usually reserved
only for abundant proteins.
 A considerable market exists for blood proteins now produced by con-
ventional blood fractionation procedures. One of the important blood clot-
ting proteins, factor VIII, is present in such low concentrations that large
volumes of blood must be processed to obtain this factor using conven-
tional procedures. Absence or deficiency of this protein results in classical
hemophilia A. Because of its scarcity and medical importance in the treat-
ment of hemophilia, factor VIII was an obvious early candidate for appli-
cation of recombinant technologies. Factor VIII is being produced by
Genentech/Cutter, Chiron and Biogen. The production of recombinant
factor VIII represents a major technological feat, since it is the largest
protein gene cloned to date.
 Another important therapeutic blood protein is tissue plasminogen acti-
vator (TPA). Developed by Genentech, it will also be produced by Biogen/
Smith, Kline and Beckman, Damon Biotech and Chiron. TPA is glycosyla-