Pharmaceutical Secondary Manufacturing - Leapfrog Time?

By Rebecca Vangenechten Life Sciences Industry Consultant, Siemens & Ivo Backx Senior Consultant for drug manufacturing, Vertical Market Management Pharma department, Industrial Automation and Drives Technology at Siemens

Pharmaceutical secondary manufacturing has long stood in stark contrast to the drug discovery end of the business, as well as to other sectors, when it comes to innovation such as continuous manufacturing. Is that about to change? Siemens’ Rebecca Vangenechten and Ivo Backx argue that the coming decade could see secondary manufacturing not just catch up but leapfrog other sectors and that mindset will be a crucial factor.

Some of the reasons that explain the relatively slow pace of secondary manufacturing change also explain why the sector is likely to see a transformation. Few other industries would survive if they presided over utilization rates around 30 or 40 percent and took as long as a month or even two months to manufacture a product that could be made in two days. Large inefficient batch manufacturing would have been consigned to the dustbin. In pharma, however, the profits that have come from the traditional blockbuster drug discovery model have masked manufacturing inefficiency and regulation has inhibited change.

Now, however, the traditional business model is breaking down with consequent pressures on all parts of the pharma value chain. Manufacturing’s contribution to improving yield, reducing time, cost and waste is increasingly critical. Regulation that previously had insisted on batch testing is now moving to be much more supportive of real-time product release and process analysis, heralding a future where the validation and establishment of continuous manufacturing will be easier.