Reducing the Time To Market From Fast to Ultrafast Track – Why Big Pharma Kicks Into Overdrive

Author / Editor: Gert Moelgaard / Anke Geipel-Kern

For many years the challenge of bringing down time to market has been a main driver within pharmaceutical manufacturing — The results have been mixed and there is no clear winning concept yet. Within product development, there are methods available to significantly shorten the time from a pivotal phase 2 clinical study to a full-scale commercial manufacturing. For pharmaceutical production, the need on new production technologies for fast track implementation and commissioning as time to market driver is getting more and more important.

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Time to market is a key issue for all manufacturing companies. In the pharmaceutical industry, it is complicated by the fact that uncertainty from clinical trails has become so significantly that most companies wait until the result of a pivotal phase II clinical trial or even a phase III result before they commit the necessary investment for the capacity of producing a new drug.

For years, the time to market driver has been how much planning can be done without committing to investment projects by purchase order and execution - and still hit the market as soon as the marketing authorisation of a new drug is received.

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Some engineering and equipment companies have specialised in this fast track niche and there has been a number of technologies and methods to deliver really fast facility projects based on parallel execution and/or modular facility solutions with several success stories.

However, we are approaching a new pharma reality where products may be approved significantly faster than so far. New regulatory programs support fast track product approvals and looking across some of the most significant drug approvals within the last couple of years, some of them are coming scaringly fast - from an engineering and supply chain perspective …!

Besides, drugs approvals often follow a new strategy of showing “proof of concept” on a small disease indication and then increase by additional clinical studies of more indications. Some of the next generation of monoclonal antibodies and immunotherapies are following this strategy and for some of them it has led to approval for new indications within very few weeks. This puts a significant challenge on manufacturing ca­pacity — and even more on the flexibility.

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?

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