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DSM to offer clinical trial manufacturing services

By Emilie Reymond , 09-Jan-2007

DSM Pharmaceuticals is showing no sign of slowing down as it continues to invest in the expansion of its pharmaceutical production capabilities - the latest being the completion of a revamped sterile parenteral manufacturing plant located in the US which will provide pharma firms with clinical studies services.

The company has announced the addition of a clinical trial material manufacturing suite at its facility in Greenville, North Carolina, which is now capable of manufacturing large and small molecule liquid and lyophilised products for Phase I to Phase III clinical trials.

The Dutch firm's pharmaceutical division is a hive of activity and this new expansion will help it focus on vial production for injectables and comes just over a year after it expanded its liquid filling and lyophilisation capabilities.

 

This latest move also sees the company getting ready to undertake cytotoxic manufacturing for cancer drugs by the end of the year.

 

The increasing influx of biopharmaceuticals, especially sterile injectables, has created many opportunities for specialised manufacturing technologies as necessary capabilities are usually not available in house for pharmaceutical and biopharmaceutical companies.

 

Lyophilisation, in particular, is a process that is in growing demand in the biopharmaceuticals segment, as it requires a high degree of automation, and contract manufacturing organisations (CMOs) are focusing on tapping this large demand for such specialised niche technologies.

 

CMOs like DSM Pharmaceuticals, who have spotted the opportunity in the market, have been building state-of-the-art facilities that rival those of pharmaceutical companies and are constantly upgrading them to enable novel manufacturing processes.

 

This new facility will provide pharma companies with full life cycle management support for sterile parenteral drugs from the earliest stages of production all the way to market launch and beyond, the company said.

 

"What's resulted is an expanded service offering consistent with the level of high quality service and deliverables our customers have come to expect from DSM," said Terry Novak, chief marketing officer for DSM Pharmaceuticals.

 

"For customers with sterile products in development, they can now start with DSM in clinical trial manufacturing and stay with DSM through commercial manufacturing."

 

In addition, the new service combined with optional support services such as Quality Assurance (QA) Audits, regulatory support, lyophilisation cycle development, analytical methods development and testing provide DSM customers with comprehensive services, consistency and support, the company said.

 

"We have taken this capability one step further," said Hans Engels, chief operating officer at DSM Pharmaceuticals.

 

"By simplifying the business functions and operations to include standardised documentation and open up front pricing, so there won't be any surprises."

 

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