For the past decade pharmaceutical companies have focused on new production models to meet the shift in demand from blockbusters to small volume manufacture of niche and personalised drugs. As a result, mobile, compact, green and cost-effective technologies are in demand to provide the new flexible manufacturing structure. Cost cutting is high on the agenda, therefore reducing or combining process steps where possible is a win-win.
Also key to achieving this transition is the switch from the traditional multi-step, multi-location batch production process to continuous manufacturing – connecting all the manufacturing operations into one flowing production stream. However, achieving such a transition demands not only new production equipment but also improved analytical technology, better process control and computer modelling to ensure products stay within the required safety and quality parameters. There is also the issue of providing traceability without the traditional divisions of different batches.