It is broadly accepted that we see a mega–trend towards smaller products and smaller batch sizes. The requirements for much increased flexibility and the span between small and big products in a facility are becoming a manufacturing challenge. And this is probably only the beginning: As we approach personalized medicine from many angles, we will see new manufacturing challenges and see technologies that are not well known today and could become mainstream yet.
From a pharmaceutical manufacturing perspective we must expect more small products and more small batches when we look into the new products coming through the pipeline of the R&D based pharmaceutical companies. We have seen the trend for a few years now, but it is not mainstream yet and most pharmaceutical companies are not well prepared for the impact from a manufacturing and technology perspective.
Some pharma companies know this well. They have years of experiences in small products such as orphan drugs and other niche medications and treatments for small diseases or even rare diseases. These products are becoming normal, but so far the orphan drug companies have each found their own solutions to the challenges and very few of the big pharmaceutical equipment suppliers have given it much attention.
There are exceptions of equipment for small products like for clinical manufacturing, where there is a lot of manufacturing technology available, but clinical manufacturing is a special area. There will be an increasing need for more flexible equipment that produces both small and large volumes of the increased number of small products, that are coming. Not the very large volumes, but still large volumes.
Prerequisite for Personalized Medicine
Some companies are going even further than the orphan drug companies. Some pharmaceutical companies are dealing with personalized medicine in the sense that the products are based on patient supplied material such as blood, tissue or certain cell types. For example this type of immunotherapy is growing and there are several new products and treatments in the pipeline for e.g. cancer treatment. The immunotherapy manufacturers are living with these challenges, but also this has mainly been a niche area and has not become a standard manufacturing technology yet.
Pharma equipment suppliers should see the writing on the wall. The trend towards smaller products, smaller batches and even all the way down to personalized medicine is coming. Personalized medicine is a very broad term and actually it is a new paradigm in the pharmaceutical industry that thought-leaders use as a strategic ambition. The manufacturing tech-nology is not established yet and we know that it will have to be. Until now much of the commercial manufacturing for these treatments has been done in small scale facilities that are constructed as a type of laboratories. As long as the manufacturing scale is small, it works, but it is a pre–industrial approach. Manufacturing is of course possible, but it will be hard to achieve economy of scale if the new immunotherapy products succeed as they are expected to. We don't have proven commercial solutions for large scale manufacturing yet. The techno-logy and manufacturing is still immature like back in the era of car manufacturing before Henry Ford or film processing before George Eastman's Kodak.
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