PacificGMP, Actinium in cGMP Bio-Pact

Posted on November 20, 2008 @ 06:20 am

PacificGMP has entered into a cGMP contract manufacturing agreement with Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer. 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 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.

For breaking news from this year's AAPS conference, visit our Live from AAPS site!