Medicago gets CGMP qualification for flu-vaccine plant
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Apr 16, 2008 07:18AM
Commercialization of protein-based vaccines & biopharmaceuticals
Mr. Andy Sheldon reports
MEDICAGO COMPLETES CGMP QUALIFICATION OF ITS MANUFACTURING FACILITY
Medicago Inc. has successfully completed the Current Good Manufacturing Practices qualification of its manufacturing facility located in the technology park of Quebec. CGMP rules and regulations governing the development, manufacturing and control of pharmaceutical products apply to all stages of production, from early development to marketed products. This qualification will allow Medicago to produce clinical-grade materials of H5N1 avian influenza virus-like particles vaccine candidates and other influenza vaccines.
"The qualification of our facility and quality control procedures to meet the CGMP and ISO standards are another important milestone in our program to advance our VLP pandemic influenza vaccine candidates," said Andy Sheldon, president and chief executive officer of Medicago. "We are now in a position to take full advantage of our manufacturing capability and initiate the production of VLP vaccines this year to support our human clinical trials."
"CGMP qualification is always a great challenge for all companies and we are especially proud that Medicago has attained this level of excellence," said Louis Vezina, chief scientific officer. "Now that we have achieved this milestone, we have strengthened our competitive position for all our products."
Medicago's facility is made up of 11,000 square feet of biosafety Level 2 greenhouse spaces for plant growth, as well as 3,000 square feet of CGMP manufacturing suites for plant manipulation, product recovery and purification.