Medicago completes cGMP qualification of its manufacturing facility
Medicago Inc. announced that it has successfully completed the current Good Manufacturing Practices ("cGMP") qualification of its manufacturing facility located in the Technology Park of Québec City, Canada. 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 ("VLP") 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 CEO 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."
Medicago's facility is made up of 11,000 sq. ft. of Biosafety Level 2 greenhouse spaces for plant growth, as well as 3,000 sq. ft. of cGMP manufacturing suites for plant manipulation, product recovery and purification.
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