Laureate Pharma to Collaborate with Boehringer Ingelheim

PharmaManufacturing.com
02/06/2007

Laureate Pharma, Inc. on Feb. 6 announced a preferred partnership agreement with Boehringer Ingelheim. The collaboration will give Laureate’s clients access to Boehringer Ingelheim’s comprehensive manufacturing technology platform for biopharmaceutical products produced by mammalian cell culture.

Through this collaboration, Laureate will now offer its clients bioprocessing services that include:

• Creation and development of production cell lines using Boehringer Ingelheim’s efficient BI HEX expression system;



• full-service process development and manufacture of early-stage clinical supplies at Laureate’s cGMP manufacturing facility in Princeton, N.J.; and



• access to large-scale commercial production by Boehringer Ingelheim at its facility in Biberach, Germany.

Laureate and Boehringer Ingelheim have said they will harmonize bioprocessing methods to ensure seamless transfer of manufacturing activities from Laureate to Boehringer Ingelheim.

“We are delighted to announce our preferred partnership with Boehringer Ingelheim and view it as a great way to provide our clients with a complete path from clinical-scale production at Laureate to large-scale commercial manufacturing at Boehringer Ingelheim,” said Robert J. Broeze, Ph.D., president and CEO of Laureate Pharma. “Working together, Laureate Pharma and Boehringer Ingelheim offer a comprehensive menu of manufacturing solutions in the United States and Europe.”

The collaboration with Boehringer Ingelheim complements Laureate’s current service offerings with high-expression cell line development along with large-scale manufacturing capabilities to increase speed and flexibility.

“With Laureate Pharma, Boehringer Ingelheim complements its worldwide strategic manufacturing network with a strong partner for process development and clinical material supply. Our process know-how allows state of the art and time to clinic development at Laureate as well as smooth technology transfer to Boehringer Ingelheim’s commercial manufacturing,” commented Dr. h.c. Rolf G. Werner, Senior Vice President, Corporate Division Biopharmaceuticals.

About Laureate Pharma

Laureate Pharma is a full service biopharmaceutical development and protein production company located in Princeton, N.J. It provides a wide range of specialized product development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding testing, validation, analytical services and regulatory support.

Laureate is focused on two active segments of the biopharmaceutical industry: monoclonal antibodies and recombinant protein products. Mammalian cells are grown in stirred-tank or hollow-fiber bioreactors for production of biopharmaceutical proteins, which are purified by semi-automated chromatography systems and filled into vials under stringent aseptic conditions. Laureate Pharma, Inc. is a partner company of Safeguard Scientifics, Inc. (www.safeguard.com), which builds value in high-growth, revenue stage information technology and life sciences businesses. For more information on Laureate Pharma, visit www.laureatepharma.com.

About Boehringer Ingelheim

The Boehringer Ingelheim group, headquartered in Ingelheim, Germany, is one of the world’s 20 leading pharmaceutical companies. In addition to captive use manufacturing, Boehringer Ingelheim is operating a contract development and industrial customer manufacturing business for biopharmaceuticals.

Boehringer Ingelheim has developed highly efficient mammalian expression systems for CHO cells, which presently allow productivities of more than 4 g/L in animal component-free media. The Boehringer Ingelheim High Expression System (BI HEX) allows the development and production of high-quality products in a time-to-market approach and with economy of scale. For the mammalian cell culture products, a total capacity of 180,000 L is available, with a scale-up capacity that ranges from 80 to 15,000 L per bioreactor train and downstream processing systems, which are matched to the scale of the production capacity.

For more information, see www.boehringer-ingelheim.com/biopharm.