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PacificGMP and Actinium Pharmaceuticals, Inc. Announce Agreements for cGMP Antibody Manufacturing and Stability Testing



11/20/2008 8:06:26 AM

SAN DIEGO, Nov. 20 /PRNewswire/ -- PacificGMP, the leader in single-use bioprocessing for development and manufacturing, has entered into a cGMP contract manufacturing agreement with Actinium Pharmaceuticals, a biopharmaceutical company developing new targeted therapies for cancer. 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.

About PacificGMP

PacificGMP is a contract manufacturer and industry leader in single-use technology for development and manufacturing of biologics. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time required to initiate production. Benefits to clients include rapid project turnaround and the most cost effective solution in the industry. PacificGMP partners with drug developers by providing a range of cGMP and non-GMP services from cell line optimization, early process design, development and scale-up, to preclinical, clinical manufacturing, aseptic filling, testing, analytical services and regulatory support. More information can be found by visiting the Company's web site at www.PacificGMP.com.

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. is engaged in the development and commercialization of alpha particle immunotherapeutics based on its unique patent position for the utilization of actinium-225 and bismuth-213. It has facilities in Florham Park, New Jersey and Oak Ridge, Tennessee. More information can be found by visiting the Company's web site at www.actiniumpharmaceuticals.com

CONTACT: Gary Pierce, Chief Business Officer of PacificGMP,
+1-858-550-4094

Web site: http://www.pacificgmp.com/
http://www.actiniumpharmaceuticals.com/


Read at BioSpace.com

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