Breaking News on Global Pharmaceutical Technology & Manufacturing
Contract manufacturing news in brief
By staff reporter, 04-Jul-2007
Related topics: Contract services (outsourcing), Ingredients
Agilent, Goodwin Biotechnology, IntegrityBio, Vastox, and AMRI have all made new contract manufacturing announcements this past week.
Biotechnology company Intradigm has selected Agilent to manufacture the active small interfering RNA (siRNA) component of its lead RNAi therapeutic in order to support the initiation of clinical development, expected in 2008.
Intradigm will then use its proprietary RNAi Nanoplex delivery system to encapsulate the nanoparticle-based drug.
The compound, ICS-283, is an anti-cancer agent being developed against a novel target, vascular endothelial growth factor (VEGF), and is geared towards treating "a variety of cancer indications," said Intradigm.
Similarly, Neogenix Oncology has recruited Goodwin Biotechnology to assist in the process development and manufacturing of its first investigational compound, NPC-1C, a preclinical monoclonal antibody intended for the treatment of advanced pancreatic cancer.
The young biotech firm is counting on Goodwin to help it "produce a high quality antibody that will allow us to enter Phase I and II trials as soon as possible," ideally by the first half of 2008.
Meanwhile, Vastox has completed the construction of its good manufacturing practices (GMP) facility located at its subsidiary company, Dextra Laboratories, in Reading, UK, which it will now use for both in-house and fee-for-service manufacturing.
Dextra, which specialises in carbohydrate chemistry, will now have the capability to produce clinical trial quantities of compounds up to Phase II.
Previously the company was only able to undertake scale-up chemistry and route design from a facility in Oxford, Vastox CFO Darren Millington told Outsourcing-Pharma.com.
The first product to be made there will be an in-house compound and the second will be for the facility's first client, at the end of July.
"We also have a pipeline of between six and twelve other potential clients lined up, half of which will convert into contracts, so we expect to have the site running at full capacity before long," said Millington.
In similar news, contract research formulation and manufacturing provider IntegrityBio has opened its fill and finish facility for preclinical, Phase I and II stage infusion- and injection-based products.
The new GMP-certified facility, located in Camarillo, California, can cater for up to 10,000 liquid formulation vials or 3,000 lyophilised formulation vials per lot, the firm said.
Meanwhile, AMRI has now completed the acquisition of two pharmaceutical manufacturing sites in India, in a deal that was first announced in May.
Under the arrangement with India's Runwal Group, AMRI will acquire the assets, including facilities, employees, products and equipment, of Ariane Orgachem in Aurangabad and Ferico Laboratories in Navi Mumbai for around $11m (€8m) in cash.
The facilities make a wide range of pharmaceutical intermediates and bulk active ingredients, including treatments for diabetes, heart disease and asthma. In the fiscal year 2006, these assets collectively generated revenues of around $5m.
AMRI said it has also obtained additional land at the Aurangabad site and plans to invest $15m to expand and upgrade manufacturing capabilities there over the next three years.
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