Austrianova Facility Commissioned For GMP Manufacturing
Austrianova
announced
today
that
its
facility
in
Bangkok,
Thailand
has
been
externally
assessed
as
being
ready
to
manufacture
biologic
products
under
current
Good
Manufacturing
Practice
(GMP).
The
assessment
was
issued
by
Chamow
&
Associates,
a
U.S.
based
expert
biopharmaceutical
consulting
company
that
specializes
in
inspection
of
facilities
for
GMP
compliance,
working
on
behalf
of
Austrianova’s
partner
PharmaCyte
Biotech
Inc.
The assessment process was initiated with a site visit and audit of Austrianova’s facility in Bangkok, Thailand at the end of last year, followed by a comprehensive evaluation of key documents such as the quality management system manual and numerous key facility related standard operating procedures (SOPs) for compliance with US--FDA requirements for GMP pharmaceutical production facilities. The assessment process also included validation that all facility related equipment has completed the Installation Qualifications (IQ) and Operational Qualifications (OQ).
Earlier this year, Austrianova began offering new cell banking and filling services called GMP4Cells that includes Master Cell Bank (MCB) and Working Cell Bank (WCB) production as well as a “Fill and Finish” service for cell therapy products (e.g. stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc). GMP4Cells is provided in addition to Austrianova’s more well established Cell--in--a--Box® cell encapsulation services.
“We are pleased to reach this important milestone for our GMP facility, which we believe to be the first of its kind world--wide. Thanks to the extraordinary efforts of our staff and our partners, the whole process has been completed in record time”, stated Walter H. Gunzburg, Chairman and CTO of Austrianova. “This assessment of GMP readiness by an independent company can be added to growing list of achievements and successes that include last years audit of the facility by a WHO--accredited inspector as well as a recent positive site visit from the national regulatory agency” said Brian Salmons, CEO of Austrianova.
The assessment process was initiated with a site visit and audit of Austrianova’s facility in Bangkok, Thailand at the end of last year, followed by a comprehensive evaluation of key documents such as the quality management system manual and numerous key facility related standard operating procedures (SOPs) for compliance with US--FDA requirements for GMP pharmaceutical production facilities. The assessment process also included validation that all facility related equipment has completed the Installation Qualifications (IQ) and Operational Qualifications (OQ).
Earlier this year, Austrianova began offering new cell banking and filling services called GMP4Cells that includes Master Cell Bank (MCB) and Working Cell Bank (WCB) production as well as a “Fill and Finish” service for cell therapy products (e.g. stem cell therapies as well as biologics produced from cells such as vaccines, antibodies, recombinant proteins etc). GMP4Cells is provided in addition to Austrianova’s more well established Cell--in--a--Box® cell encapsulation services.
“We are pleased to reach this important milestone for our GMP facility, which we believe to be the first of its kind world--wide. Thanks to the extraordinary efforts of our staff and our partners, the whole process has been completed in record time”, stated Walter H. Gunzburg, Chairman and CTO of Austrianova. “This assessment of GMP readiness by an independent company can be added to growing list of achievements and successes that include last years audit of the facility by a WHO--accredited inspector as well as a recent positive site visit from the national regulatory agency” said Brian Salmons, CEO of Austrianova.