The development of a new, innovative drug is a highly complex and cost-intensive technical task. It normally takes more than 10 years from initial idea to first approval of a drug. As the statutory requirements for patient safety have become ever more stringent in recent years, development expenditure has increased significantly. High investment costs needed to develop some drug products are estimated to be 1â€“1.6 billion US dollars, which can be amortized only after market launch (1). The race against time for patients and valuable new active agents begins long before a new drug can be
used to save lives.
Given the time pressure to achieve rapid market launch of a drug, innovative solutions are called for to reduce project lead times and to meet ever-increasing quality requirements. The scale-up process for producing active pharmaceutical ingredients (APIs) requires a wide range of outstanding engineering skills, all of which ZETA can
provide optimally by means of system-controlled knowledge transfer. ZETA supplies solutions along the entire API production process. The company proved its expertise recently with a new, integrated, software-based process planning tool that reduces project lead times by 30%.
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1 The Current State of Innovation in the Pharmaceuticals Industry. CRA International: London, 2008.