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Breaking News on Contract Research, Manufacturing & Clinical Trials

 

Contract manufacturing news in brief

20-Jun-2005

In-PharmaTechnologist provides its periodic round-up of new deals and developments in the pharmaceutical contract manufacturing sector.

Portugal-based Hovione has entered into a long-term manufacturing agreement for the supply of Efaproxyn (efaproxiral sodium) for the US's Allos Therapeutics. Efaproxyn is the first synthetic small-molecule agent designed to sensitise hypoxic, or oxygen-deprived areas of tumours during radiation therapy by facilitating the release of oxygen from haemoglobin.

Under the terms of the deal, financial details of which were not revealed, Hovione is committed to manufacture and supply Allos with sufficient quantities of efaproxiral sodium to support the firm's anticipated requirements for both the pre-and post-commercialisation phases of production, the groups said.

This marks the most recent step in a partnership between the two companies that began in 1997. Under a prior agreement between the parties, the Portuguese firm manufactured the majority of the bulk drug substance used by Allos in its clinical trials of Efaproxyn.

Boehringer Ingelheim Austria is to manufacture Corautus Genetics' VEGF-2 (vascular endothelial growth factor 2) plasmid DNA for Phase III trials and future commercial use for the treatment of severe angina and other indications. The Austrian company began the feasibility and GMP implementation activities for the project several months ago.

Boehringer Ingelheim Austria said it won the contract because its scaleable plasmid manufacturing technology can achieve titres of up to 1g pDNA per litre fermentation suspension and drug substance purity of 99 per cent, which it said 'leads the industry'.

US contract manufacturer Omnia Biologics has formed an alliance with the University of Maryland Bioprocess Scale-Up Facility (BSF) to cooperate in providing services for the manufacture of biopharmaceutical products. The aim is to combine BSF's scale-up fermentation and training expertise with Omnia's GMP processes, class 100 sterile fill-finish, and BSL-3 suites.

Sterigenics International, which provides contract sterilisation services, will add significantly to its European and Asian capacity with the opening of two new facilities in Germany and China.

This month, Sterigenics will commence operations at its ethylene oxide (EO) processing facility in Wiesbaden, Germany. Sterigenics will use the new Wiesbaden facility to introduce its break-through CyclEOne technology to the European market. CyclEOne preconditions, processes and aerates in a single chamber in a single day, trimming 9 to 13 days from the conventional EO processing cycle.

In September, the company will open an Electron-beam (E-beam) facility in Shanghai, China, to provide sterilisation of items such as surgical dressings, non-woven surgical drapes and gowns and simple plastic devices.

UK cancer drug developer Antisoma has signed an agreement with German contract manufacturer Heraeus to provide supplies of AS1410 - a telomere-targetting agent - for clinical trials. The UK firm now expects to start clinical trials in the first half of next year.

Data presented at the 2005 meeting of the American Association of Cancer Research showed that treatment with AS1410 more than halved the growth rate of a human prostate cancer xenograft.

US-Israeli firm Inotek Pharmaceuticals - which develops its own products as well as offering analysis, synthesis and pharmacology services - has acquired a 30,000-square-foot GMP manufacturing facility in Dimona, Israel. The manufacturing plant provides Inotek with the ability to manufacture drugs for Phase I and Phase II clinical trials, produce pilot-scale quantities of drug for research and development programs, and potentially provide commercial quantities for approved drugs.

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