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Contract manufacturing news in brief

By staff reporter , 25-Feb-2008

Dextra Laboratories, Akorn, Metrics and Xcelience have all recently announced new contract manufacturing news.

Dextra Laboratories, the specialist carbohydrate chemistry subsidiary business of UK biotech firm Summit Corporation, has just signed service contracts with four undisclosed biotechnology companies.

 

 

 

The contracts total an initial £500,000, however, the firm said that the value of these deals could rise to over £1m within the next six months.

 

 

 

For its new clients, Dextra will develop efficient routes of compound synthesis and good manufacturing practice (GMP) product supply for their drug development programmes.

 

 

 

Steven Lee, CEO of Summit said that carbohydrate chemistry "is becoming an increasingly important area for the discovery, development and manufacture of new and often difficult to synthesise drugs and healthcare products".

 

 

 

Dextra will conduct the work from its GMP facility in Reading, UK, which was completed in June last year. The company said the deals represented the first significant return on its investment in the new GMP plant.

 

 

 

"This [GMP] capability proved to be a key factor in the signing of these deals as it permits the company to produce material suitable for use in human clinical trials up to the Phase II stage of development", Dextra added.

 

 

 

This week, Akorn said it has signed a five-year contract agreement with a "major" undisclosed US pharmaceutical company, whereby it will be responsible for the manufacturing and supply of the firm's ophthalmic drug product from its facility in New Jersey.

 

 

 

The firm specialises in the manufacturing of ophthalmics, liquid injectables and lyophilised products.

 

 

 

Akorn already holds the abbreviated new drug application (ANDA) for the eye drug solution product and said it is planning to launch the drug under its own name by the middle of this year into a $25m market opportunity.

 

 

 

Meanwhile, US Lab services firm Metrics is in the midst of an $18m expansion plan that will involve a 47,000-square-foot facility addition, increase its potent and cytotoxic drug handling capabilities and double the capacity of its facility in Greeneville, North Carolina.

 

 

 

The site existing site currently holds 44,000 square feet of drug R&D, large scale manufacturing (Phase III to commercial) and stability storage space, as well as a microbiology lab and a lab for potent compound work. Metrics said the expansion will allow its clients to keep development and commercial manufacturing projects under the same roof.

 

 

 

As part of this, the company recently opened four new analytical labs, increasing the site's lab capacity by 40 per cent. Metrics said it expects to begin accepting contract work in the new facilities during the second quarter of this year once they receives validation.

 

 

 

To assist with the expansion, Metrics received a $150,000 One North Carolina Fund grant and said it plans to create 77 new jobs.

 

 

 

Overseeing the expansion is Joe Cascone, the company's new director of potent pharmaceutical development.

 

 

 

Cascone previously served as manager of pharmaceutical development at Metrics, where he was directly responsible for all aspects related to the formulation of solid-oral and liquid-dosage forms for high-quality, fast-track contract GMP pilot-plant supporting pre-clinical to phase III projects.

 

 

 

In other news, formulation development firm Xcelience said it has become the first contract manufacturer in North America to purchase the Xcelodose 600 S precision powder micro-doser and automated encapsulator, made by Capsugel.

 

 

 

According to Xcelience, the S model fills at speeds of over 600 capsules an hour at 50 per cent greater throughput than its predecessor, the Xcelodose 600.

 

 

 

The company expects to begin using the new machine by May.

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