Searching for scalable processes: addressing the challenges in times of increasing complexity.

The position of the pharmaceutical industry at the beginning of the 21st Century and its role in process research and development are important considerations. Based on recent figures and statistics, it is evident that new and maybe unorthodox ways of operating need to be envisaged to counteract the explosive rise in research and development costs (> US $800 million per successful launch in 2002) and the worryingly high level of attrition (approximately 90%), which, in addition to long handling times for authority approval, lead to a continued decline in the number of drugs entering the market. In addition to pointing out these harsh realities, it is essential to remember that the time taken to bring a new product forward is crucial. In this context, a front-loading model has been developed and applied in AstraZeneca's process research and development. The enormous implications of chirality in the pharmacological arena have been fully acknowledged for many years, and sales figures of chiral molecules corroborate the importance of this feature. The methodologies that are available to address the design and scale-up of production methods are also reviewed against a backdrop of recent in-house cases.