Manufacturing and development services news in brief

Rentschler Biotechnologie​ has brought a new 2,500-litre multi-process production suite online to boost its ability to provide contract manufacturing and development services aimed at the production of biopharmaceuticals in mammalian cells, The company says it now has nine stand-alone suites with volumes of 30, 250, 500 and 2,500 litres, allowing the production of material for clinical trials and for market supply. Rentschler also has an agreement with Boehringer Ingelheim so it can offer large-scale bioreactor volumes of up to 15,000 litres if required. The new bioreactor is designed to handle batch, fed-batch, or perfusion cell culture processes, while protein purification is performed in two suites for pre- and post-virus inactivation, respectively. Since 2002, Rentschler has invested more than €70m ($110m) in its production capacities in order to meet rising demand for biologics production, and now claims to be among the top three European CMOs serving this sector. Eden Biodesign​, which specialises in mammalian, microbial and viral biopharmaceutical production, is expanding its US subsidiary via the establishment of a facility in the Research Triangle Park, North Carolina. The company will offer a range of cell line/strain development and early process development services at the site, and the subsidiary will make it easier for clients in the US "to access Eden's proven expertise and inspected cGMP manufacturing facilities​," said CEO Crawford Brown. Eden recently appointed of Michael Faughnan as business development director, who will support the US drive from his base in Southern California. A new company specialising in drug delivery and design, Appian Labs​, has been set up with the backing of venture firm Emergent Technologies​. The company will offer its services in solving a number of drug delivery problems, including poor bioavailability or solubility, dose timing, toxicity and many others. The company has a proprietary drug delivery platform - AppiForm - which can be used to provide tablets, minitablets or capsules, including mico or bioadhesive formulations. The scientific arm of the business is led by Nicholas Peppas, the Fletcher S Pratt Chair of Chemical Engineering, Biomedical Engineering and Pharmaceutics at the University of Texas at Austin, US, while the commercial aspects are under the direction of president Brian Windsor, who is senior vice president, portfolio company management for Emergent. Indian contract manufacturer Emcure Pharmaceuticals​ has brought a new active pharmaceutical ingredient (API) and formulations plant for oncology medicines online, and expects to start filling products from November 2008. The company has invested more than $25m in the unit, which makes use of "the latest isolation technology that will ensure protection of the products, operating personnel and environment.​" It is based in Hinjwadi, Pune. "The oncology market in India is estimated at 400 crores [$94m] and is growing at the rate of 30 per cent. We aim to achieve 15-20 per cent market share in this segment within next 5 years​," said Satish Mehta, Emcure's CEO. Meanwhile, the company has also inaugurated a malaria vaccine manufacturing facility, operated by subsidiary Gennova Biopharmaceuticals, that will make clinical trial materials (CTM). This unit is also based in Hinjwadi and will start production in October.