For large-scale manufacture of one or more monoclonal antibodies under FDA-compliant conditions to isolate MPC, Mesoblast will contract a leading manufacturer of GMP monoclonal antibodies with extensive experience in the stem cell field and in dealing with the FDA approval process. The FDA-compliant monoclonal antibodies will preferentially bind to and be used to isolate an enriched population of MPC from a mixed starting cell population. The MPC are then grown in the laboratory under Mesoblast's FDA-compliant manufacturing conditions. Initial batch manufacturing will be outsourced to a world leading company specializing in GMP production of cells meeting FDA requirements for human therapy. Mesoblast will oversee all technology transfer and process development, culminating in validation runs on the suite of procedures needed to produce MPC suitable for clinical trials in both orthopaedic and cardiovascular diseases.
Product Development
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