Pharma manufacturing news in brief
pharmafile | August 13, 2010 | News story | Manufacturing and Production |Â Â Dutch CMO SynCo Bio Partners, GeoPharma, Merck & Co, Positron, SCM Pharma, Thermo Fisher ScientifiticÂ
EMA and FDA issue call for volunteers for joint inspection pilot, plus facility updates from Merck & Co, Thermo Fisher and Positron and CMO news from SCM Pharma, SynCo and Geopharma.
The European Medicines Agency and US Food and Drug Administration are looking for companies to participate in their pilot joint inspection programme for manufacturing facilities. The two regulatory agencies particularly want to identify companies that have submitted parallel marketing applications for the same product in both the EU and the US. The scheme, which aims to make better use of inspection resources at the regulators, was first set up in 2008.
Merck & Co has agreed to buy back a US manufacturing facility in Philadelphia, which it sold to a contract manufacturer in 2008, after the new owner struggled to expand the business. PWRT bought the Cherokee Pharmaceuticals facility along with a five-year, $900 million contract to continue to make certain key Merck products, but said it had been unable to win enough additional contracts from other companies. Merck said it had decided to repurchase the facility to avoid disruption in its production.
UK-based contract manufacturing organisation (CMO) SCM Pharma has been selected by Sanofi-Aventis to provide fill and finish services for a radio-labelled anticancer product which is currently in clinical trials. The unidentified drug will be filled using isolator technology in SCM Pharma’s cleanroom facilities in Northumberland and sent to Sanofi-Aventis for packaging and distribution to clinical sites.
Thermo Fisher Scientific has expanded its manufacturing capability in Shanghai, China, for the production of its Nunc Cell Factory single-use, certified-sterile bioprocessing systems. The company also makes the product range at sites in New York, USA, and Roskilde, Denmark. The expansion is part of a strategy to invest in regional production of its bioprocessing products to support local bioproduction of vaccines, cell and protein therapeutics.
Positron Corp of the USA has opened a new GMP facility in Indiana to manufacture radioactive and non-radioactive pharmaceutical products and devices. The plant will focus initially on the manufacturing of pharmaceuticals used in positron emission tomography (PET) scanning, both for internal use and on a contract basis.
Dutch CMO SynCo Bio Partners has been contracted to scale-up a manufacturing process for an extended-release human growth hormone product (VRS-317) in development at US biotech Versartis, and also to provide fill and finish services for the manufacture, testing and release of formulated drug product vials. The CMO already has a contract to provide similar services for Versartis’ lead product VRS-859 (exenatide-XTEN) for diabetes.
GeoPharma has sold off all the assets of its contract manufacturing unit Belcher Pharmaceuticals to a privately-held concern, as part of a restructuring programme aimed at reducing its debt and placing it on the path to profitability. The company says it intends to focus on its core business of contract manufacturing dietary supplements and other health products.
Phil Taylor
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