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Therapeutic Proteins Inc. Completes First Independent, Dedicated Biosimilars Manufacturing Facility in U.S.
Date:4/22/2010

Company To Produce Ingredients for Follow-on Biologics in Chicago.

Chicago (Vocus) April 22, 2010 -- Therapeutic Proteins Inc. (TPI) today announced the completion of the nation’s first independent, dedicated, follow-on biologics (or biosimilars) manufacturing facility constructed to meet U.S. Food and Drug Administration (FDA) requirements. The Chicago facility is located at University Technology Park at IIT (Illinois Institute of Technology).

Therapeutic Proteins Inc. has developed several off-patent biological drugs (recombinant proteins) used as life-saving therapies and which comprise a significant part of the total biological drugs market of around $40B. TPI only produces the therapeutic proteins as active pharmaceutical ingredients (API) for pharmaceutical manufacturers to formulate, package and sell these products to consumers. With the completion of the company’s new manufacturing facility in the U.S., TPI will be able to produce FDA-regulated API’s domestically, which goes against the trend of outsourcing manufacturing to other countries.

“We anticipate exporting bulk API in the fourth quarter of this year, and we will submit BLAs (biological license applications) to the FDA for new products once the agency establishes guidelines for biosimilars,” said Thomas L. Flynn III, CEO of Therapeutic Proteins. “The newly enacted healthcare bill directs the FDA to establish a regulatory framework for the marketing authorization of follow-on biologics.”

TPI currently has 13 employees, and the company expects to create more than two dozen new high-tech jobs in Ch
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