PacificGMP, a contract manufacturer of biologics, has entered into a cGMP contract manufacturing agreement with Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer.
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Under the agreement, PacificGMP will manufacture and perform fill or finish of Actinium’s HuM195 monoclonal antibody for a Phase I/II clinical trial. A stability study of the final product will also be conducted.
HuM195 is a monoclonal antibody that is currently being tested in a Phase I clinical trial to treat acute myeloid leukemia.
Leigh Pierce, president of PacificGMP, said: “We are delighted to establish a partnership with Actinium Pharmaceuticals and initiate current good manufacturing practice (cGMP) production for their new Phase I/II clinical trial. With our strong track record of monoclonal antibody production, this project is a perfect fit for our companies and we look forward to efficiently providing Actinium with a high quality GMP product.”
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