Creative development?

Amid the excitement of new drug launches and novel research techniques, process development is invariably overlooked. Yet no moneyspinning blockbuster drugs would get anywhere near the market without the skills of development departments who create the manufacturing processes to make the chemicals for the formulators to turn into drug product.

But the crucial nature of the scale-up process is belied by the technology applied to the manufacture of the chemicals. Bar a bit of process automation, the reactors used are essentially the same as those that have been used for the past half century. It is easier (and quicker) in the short term for chemical reactions to be modified to fit into existing kit rather than inventing new reactors to accommodate the speed and exothermicity of many reactions.

With speed-to-market being the overriding factor in the development of new pharmaceuticals, there is little incentive for true innovation in chemical development. The earlier a drug is on the market, the longer a company has to exploit its patent to the full, and the amounts of money involved can run into over a million dollars a day for a major drug. So taking time out to create new processes adds to the costs.

But the current situation, where reactions are slowed down substantially in order to accommodate them into existing reactors is wasteful of time, energy and resources. If a reaction can go to completion in seconds, then how can the best way of using it on a manufacturing scale be to control it to such an extent that it takes hours to finish?

Process development is a science in itself. Novel reactor types are being developed, but there is little inclination within the pharma industry to take advantage of their potential for longer-term cost savings. But as margins are squeezed ever more tightly, and those that hold the purse strings begin to run out of the 'easier' ways to save money to keep the shareholders happy, maybe their attention will be turned to cutting costs in chemical development. And the only way this can sensibly be done is in creating and implementing innovative reactor technology. It's a shame that, with all the money that is being spent on creating new drug discovery methods and chemical reactions, so little time and effort are allocated to manufacture. In the long run, this surely will have to change  and the companies that are prepared to invest in the future will be the most likely to succeed.