September,1985, Beijing,
Prof. Sun Shiquan was
recommend meeting Dr. R. Mukherjee, the official of the
life science
department of the International Atomic Energy Agency (IAEA). Soon,
the China institute for radiation protection
(CIRP)
and the International Atomic Energy Agency (IAEA)
subscribed the
agreement of developing investigation at radiation sterilization for
tissue graft. In 1988,
CIRP held the second
Pacific Asia region tissue bank technique
training class.
IAEA
provided financial assistance
to CIRP for the equipment
of lyophilizer and ultra deep freezer to undertake the tissue
preparation. Later, China Institute for Radiation Protection Tissue
Bank was established.
The original intention of the IAEA
Region Cooperation
Agreement (RCA)
was to
establish and generalize the
irradiation
sterilization technique on tissue
processing to provide safety and effective
tissue grafts to
the clinic. So the CIRPTB concentrates on
translate its technique from the laboratory research to the clinical
application. With the second Pacific Asia region
tissue bank technique training class held successfully (1992), Shanxi Provincial Tissue Bank (SPTB) was
established
in 1994 and began to supply a batch production of
tissue grafts
to clinical practice.
SPTB is a
non-profit
organization. It engaged in the
research, education, preparation, quality control of the allograft based on
donated mankind tissue. and, it also engage the work on public awareness of tissue donation, expanding
the clinical application of tissue grafts.
SPTB also provide
implantation technique
information to the clinical doctor to
promote the development of the tissue
banking and tissue transplantation in China.
We have held two nationwide bone
transplants seminars and a bone banking training class up to now.
Along with Chinese government system reform
and the development of the clinical technique, the mankind
tissue grafts
are regulated by the State Food and Drug
Administration
and classified to the third type
of
medical device.
Its industrialized production and
sales must be licensed from SFDA for marketing of bone allografts
to the hospitals. In 1999, Shanxi OsteoRad Biomaterial Co.,
Ltd. was founded. Prof.
Li Bao
Xing,
director of Shanxi Provincial
Tissue Bank, was elected as the
general manager of OsteoRad Co.,
Ltd.
Based upon scientific management
and rigorous quality control, the yield and quality of
the allografts product ascend a new step. The yield of tissue
grafts increased by 50% in growth rate annually. Now,
our products have already been extended to more than
400 hospitals in the whole country and
about 40 thousands of patients have already
recover from
various bone illness through bone allograft implantation. Allogeneic Bone Grafts got
the first approval of productive
registration
from State Food and Drug
Administration in 2001.
OsteoRad Corporation / SPTB
has 35 employees currently,
among them
there are five professors (two
are post-graduate mentor ), four associate researchers,
four senior lab assistants,
three
high grade
technician and eight reading post-graduates.
The
OsteoRad Corporation
has already owned nine national patented products and techniques,
awarded one
of first grade prize of
ministerial science and technology advancement and one second
grade prize, and fulfilled two military
research contracts and five item
from provincial or national sections.
Now OsteoRad cover
1800 square
meters production area, including 500 square meters of
ten thousand class clean room. We
have owned one
set of advanced processing equipments and facilities and built a
series of laboratories:
pathology, chemistry, microorganism, biomechanics,
electron microscope,
animal
dissection,
and tissue engineering, etc.
