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In Small Doses

 

Despite the current economic crisis, the drug development pipeline remains robust. There are 9,605 drugs being developed this year compared to 7,322 in 2005 and 5,995 in 2000, according to the Pharma R&D Annual Review, published in May 2009 (1). Clinical trials are a critical component of the drug development process, determining which drugs will be taken to market and generate revenue to compensate for the costly R&D cycle.

Due to smaller production volumes, lines used to produce drugs for clinical trial operations have always had distinct needs in terms of processing equipment. Additionally, a number of industry trends are altering the drug development landscape, and these changes are having important effects on clinical trial and pilot drug production. This article explores some of the developing needs of drug manufacturers, and how advanced sterile filling and finishing technologies, designed specifically for pilot production and clinical trial lines, are helping to solve some of these challenges.

NEW PLAYERS, NEW DRUGS, NEW DEMANDS

Drug R&D activities have traditionally been dominated by large multinational pharmaceutical companies (Big Pharma). Now the rising number of mid-size biotech and biopharmaceutical companies moving projects into clinical trials is affecting equipment demands.

While established players typically have existing clinical trial lines up and running, this is not the case for new entrants, who, as an alternative to building their own lines, often outsource operations to CROs. This is just one reason why the global CRO market is expected to grow by 14 per cent each year over the next three years, making contract research a $35 billion industry by 2013 according to a recent report from Business Insights (2). This growth has driven the need for new and improved filling and packaging machinery with increased flexibility.


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Dieter Bandtel graduated in Industrial Engineering from the University of Applied Science in Aalen in 1984. He started working in the sales department of Bosch Packaging Technology in 1989. Since 1999, he has been responsible for product management of the Vials Liquid and Vials Dry businesses. Dieter is currently the project manager for the MHI 2020. He has been involved in market research and customer surveys conducted for the development of the MHI machine in order to meet the industry trends and market needs in clinical trials filling and packaging.
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