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Contract manufacturing news in brief

By Emilie Reymond , 01-Mar-2007

Lonza, Athersys, TyRx Pharma, JFC and Precision Pharma Services have all announced new contract manufacturing deals this week.

US biotech firm Athersys has announced it has completed the manufacturing of Multistem – a master cell bank – for Clinical Trials, which was conducted by Swiss CMO Lonza.

 

 

 

Multistem is a multipotent adult progenitor cell (MAPC)-based product, which includes stem cells that are isolated from the bone marrow as well as other non-embryonic tissue sources. These types of cells have the potential to develop into a range of cell types and can be expanded ex vivo while retaining their potency, the company said.

 

 

 

"This achievement further demonstrates that we can readily transfer the cell isolation and production processes to third parties," said BJ Lehmann, president and chief operating officer at Athersys.

 

 

 

Athersys contracted Lonza to assist it in the scale-up and manufacturing of its product, using its own production processes.

 

 

 

"Athersys's production process has proven to be robust and scalable, providing a strong foundation for conducting clinical development," said David Smith, vice president, Cell Therapy Bioservices at Lonza.

 

 

 

Athersys said that MultiStem has the potential to be used to treat patients suffering heart attacks or other ischemic injuries, such as stroke, and to support recovery following bone marrow transplantation.

 

 

 

Meanwhile, TyRx Pharma has signed an agreement with contract manufacturer JFC for the clinical and commercial supplies of TyRx's proprietary polymer.

 

 

 

Under the terms of the deal, JFC will be in charge of the manufacturing of PIVIT CRM, an innovative mesh pouch coated with TyRx's proprietary bioresorbable polymer.

 

 

 

These polymers contain the antimicrobial agents rifampin and minocycline, and are designed to enclose a pacemaker or ICD pulse generator when implanted in the body to provide protection from microbial colonization of the pulse generator during surgical implantation.

 

 

 

This new deal follows a strategic alliance that TyRx secured with C.R. Bard last January for the licensing of some of the firm's technologies.

 

 

 

In other contract manufacturing news, Massachusetts-based Javelin Pharmaceuticals has signed a two-year supply deal with US-based Precision Pharma Services for the production of its pain control drug.

 

 

 

The new product – Dyloject – will be manufactured at Precision's New York facility in anticipation of its approval for marketing in Europe, the companies said.

 

 

 

"This agreement is an important step forward in growing Javelin's manufacturing infrastructure in anticipation of initial product sales later this year in Europe," said Michael Moshman, Javelin's vice president for clinical and commercial manufacturing.

 

 

 

"Working with Precision Pharma will enable us to marshal the resources to meet future demand for Dyloject as we begin commercialising this promising analgesic with its launch in the UK in 2007."

 

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