It is not new that the pharmaceutical industry is conservative and not good at changes. This has been the case for decades – and it used to be for a very good reason: To protect quality, compliance and patients – and by that also the business. So most pharmaceutical companies are really slow to adapt changes. Also those changes that have proved to best practice. Pharmaceutical companies does not use best practice. They do what they used to do. Which is sometimes far from best practice.

At a recent event on parenteral manufacturing hosted by the German/Austrian/Swiss (DACH) affiliate of ISPE there were many best practices shared, both from originator drug manufacturing, contract manufacturing and service providers. These were examples used in real practice. Some of them have been used for almost 10 years and have proven their robustness as well as their superiority. Some are about the next generation isolators, others about the management of highly potent substances and about achieving agility and flexibility in pharmaceutical manufacturing. The event was very well attended and there were many discussions with good questions and answers. As it has been the case in most of the professional pharmaceutical events over the last decade.

Everyone understands that the pharmaceutical industry is changing and also that the regulators are starting to endorse and even encourage pharmaceutical innovation within manufacturing. The US FDA even went so far in its recent re-organisation to form the Office of Pharmaceutical Quality and the Emerging Technology Team (ETT) that will look into innovation opportunities for pharmaceutical manufacturing (among others) including technologies such as continuous manufacturing.

But at the end of the day the pharmaceutical industry questions and answers leads to very few new decisions. Even at an event such as the well-planned ISPE DACH Parenteral event I will bet that the outcome is limited. Some companies shared new solutions that improves quality, flexibility and efficiency at the same time. Solutions that works and that has been inspected and approved by regulators. But the risk of changing what you do today is still too high. So the pharmaceutical industry will probably stay conservative much longer than it has to. Maybe until one of the new technologies proves to be so disruptive that change will be necessary. Maybe until FDA endorses an Emerging Technology that starts a wakeup call to move on…?