PacificGMP and Actinium Announce Agreements for cGMP Antibody Manufacturing and Stability Testing
News Nov 21, 2008
Under the agreement, PacificGMP will manufacture and perform fill/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.
"We are delighted to establish a partnership with Actinium Pharmaceuticals and initiate cGMP production for their new Phase I/II clinical trial," said Leigh N. Pierce, President of PacificGMP. "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."
"We are excited to work with PacificGMP, a company with demonstrated expertise in biopharmaceutical manufacturing. Their capabilities and ability to quickly step into this role are precisely what Actinium was looking for in a manufacturing partner," said Howard Wachtler, President and Chief Executive Officer for Actinium.
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