A rapid production of therapeutic human drugs using modified mushrooms
may help mount a quicker response to various public health problems,
according to plant pathologists who have received a federal grant to perfect
their technique.
C. Peter Romaine, professor of plant pathology at Penn State and
holder of the John B. Swayne Chair in Spawn Science, said, "We are looking
to address several public health issues through our research."

Romaine and his colleague, Xi Chen, previously a post-doctoral scholar
at Penn State, hold the patent to genetically modify Agaricus bisporus ? the
button variety of mushroom, which is the predominant edible species
worldwide.

The Defense Advanced Research Projects Agency (DARPA) recently awarded
Penn State and Agarigen Inc., Romaine's spin-off company based in Research
Triangle Park in Raleigh, N.C., $2.2 million in initial funding under the
Accelerated Manufacture of Pharmaceuticals (AMP) program for the rapid
production of vaccines and other therapeutic proteins in altered mushrooms.
The total value of the effort, if both phases of the development program are
completed, could be up to $5.9 million.

"Our immediate research goals are to maximize the level of expression
of various biopharmaceuticals and to devise efficient and economical methods
for their extraction and purification from mushroom tissue," Romaine said.

At the end of the second year of the contract, Romaine and his
colleagues, who include Agarigen cofounder and former Penn State graduate
Dr. Donald S. Walters, Penn State post doctoral associate Dr. Carl
Schlagnhaufer and a team of nine Agarigen scientists, are expected to
demonstrate an ability to produce vaccines or other biological drugs within
12 weeks.

"It will be a blind test," said Romaine. "We will be handed genes for
vaccines, monoclonal antibodies or other therapeutic proteins, and asked to
produce them in the mushroom."

The drugs will then be extracted from the mushroom into forms that
could be administered to people. In a pending third year of the project, the
researchers are expected to show they can execute a full-scale manufacturing
effort and produce three million doses of a drug in 12 weeks.

Researchers at Penn State and Agarigen are currently focusing on
assembling gene components for expression in the mushroom, and fine-tuning
their techniques to ensure a consistently high level and quality of the
drug.

"We are evaluating different gene sequences from a broad array of
organisms to determine which provide us the highest level of drug expression
in the mushroom," explained Romaine. "It is an empirical process, but we are
leaving no stone unturned to achieve our end goal."

The Penn State Department of Plant Pathology is at
[www.ppath.cas.psu.edu]