Why Small Scale Pharmaceuticals Require Special Solutions

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Another flexibility enabler is continuous manufacturing. Some companies have seen the vision and have adapted the product and process development methods that are required in order to get continuous manufacturing approved. There are not many examples of commercial continuous pharmaceutical manufacturing yet, but there are some and they already have significant experiences from regulatory approvals and commercial manufacturing.

One experience is that continuous manufacturing gives a flexibility that no other technology can provide. In short, a “batch size” is only a matter of how long you let your manufacturing run. A continuous manufacturing facility is highly flexible on volume and also much more cost-effective once it is up and running.

And what´s with the traditional approach?

The traditional pharma manufacturing approach with batch-based manufacturing requires the manufacturing system to be designed around the expected volume of the manufacturing. And it affects everything: the vessel sizes, the piping, the equipment size, the facility space, the utilities etc. Many of the factors that make facility design complicated and time consuming. Single use biotech and continuous manufacturing are only two of many examples. Some of the pharmaceutical equipment manufacturers have been early adopters and have already flexible solutions on the market, but it is still far from mainstream as we need it to be. Also the full scale manufacturing examples are still few, but some are already in full commercial manufacturing and are harvesting important experiences to the industry that other companies can benefit from.

There is lots of inspiration in the new facilities that have been built or re-built over the last few years. There are very few breakthrough facilities to refer to, but many small new innovations in many of the recent facilities, which point into the future. However, the new breakthrough facilities are coming.

Several of the big pharma companies have announced investments both in the US, UK, Germany, India and elsewhere that truly inspire for new solutions. Also the equipment suppliers are starting to see the need for flexible solutions and high operational effectiveness. Many of the new facilities are not in operations yet, but the next one to two years could be an indication of many of the elements that will constitute pharmaceutical “Facilities of the Future”.

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