Reducing the Time To Market
From Fast to Ultrafast Track – Why Big Pharma Kicks Into Overdrive
Looking for new solutions
So we are looking for a new generation of technology enablers that will support “ultra-fast” time to market. Only a few are on the market yet supporting "ultra-fast track" facility projects. Some are tied to flexibility, others to pre-fab solutions and then there are also a few new manufacturing paradigms in the horizon that will support these needs like e.g. robots technology. The flexibility to scale up is much supported by the single-use technology for e.g. biopharmaceuticals, fill-finish and other applications.
These are easy to scale up and the technology holds potential for faster manufacturing scale up than we have seen so far. If the future capacity has to expand significantly, single-use is not enough. At least not the way it is implemented today. Most new facilities with potential need for large capacity are taking a hybrid approach with both single-use and stainless steel solutions in an intelligent combination. There is a new wave of stainless steel “six-pack” solutions under implementation around the world and so far nothing can compete with large volume stainless steel bioreactors of e.g. 15 m3 capacity each.
But these “six-pack” facilities still take a long time to implement. The amount of engineering, construction and validation effort is expensive and time consuming to a degree that has not changed significantly over the last 10-20 years. There is more flexibility than in the past due to better yield (titer) and semi-continuous manufacturing solutions based on fed batch or perfusion, but the difference is not really significant anymore. Maybe there is a barrier to how much more effective the traditional mix of single-use and stainless steel technology can be, when it comes to time-to-market?
There are some opportunities in modular, scalable and highly automated facilities. Many years ago some of the biotech breakthrough drugs were manufactured by robots handling cages of rollerbottles and thus providing an “ultra-fast” scalability of manufacturing. Each rollerbottle was a bioreactor and there was no scale up issues because the scale up was simply achieved by adding more bottles.
As time went on, the old “rollerbottle dinosaur” facilities (almost) do not exist anymore, because they are costly and complex to operate. With next generation single-use bioreactors and next generation robots for containment operations combined with next-generation IT systems for integration and knowledge management, we may face a new opportunity to re-think the high flexibility - that also supports “ultra-fast time to market”. The technology is not yet really there. But we are waiting for somebody to take up the “ultra-fast time to market” challenge and turns it into a moonshot that surpasses the current facility practices by bringing new products significantly faster to the market than before … This challenge may be yours?