Updated on 28 April 2016
SINGAPORE: Austrianova announced 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 compay 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 USFDA 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 worldwide", stated Walter H.Gunzburg, Chairman and CTO of Austrianova.