Over the last couple of years the term continuous manufacturing has become increasingly popular in pharmaceutical manufacturing. But it is still hard to answer the question: “Which efficiency benefits can be reached with continuous manufacturing in comparison to the batch procedure?”
We do have the first practical experiences of operations that are running, if not fully continuously then at least partial. We know some of the efficiency benefits in the traditional sense, but there are many more benefits. Besides, there is a regulatory pressure to increase the interest and investments in continuous manufacturing because of some of these benefits.
A decade ago, only few people were thinking that continuous manufacturing was possible and approvable for pharmaceutical products. We have seen it for many years in other industries, for example the chemical industry, which has many similarities with the pharmaceutical industry, especially on the API side.
But the GMP regulation and the traditional conservatism on the regulatory as well as industry side made it look very difficult and hard to imagine for most people in pharmaceutical product supply.
FDA was going ahead
Although there were early signs of a change on the regulatory side, very few saw the potential a decade ago. Among the early signs was a 2003 report from the US Food and Drug Administration (FDA) with a major initiative concerning the regulation of drug product quality, called “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach”.
The intent was to encourage the early adoption of new technological advances by the pharmaceutical industry including (potentially) continuous manufacturing and the intent is still intact.
FDA is still outspoken about that continuous drug manufacturing creates opportunities that have not existed before. It will help personalised medicine, because it is very flexible, unlike traditional operations where everything has to be rigidly validated and so on and that there are many new dosage forms that could be made with the new techniques. It is also perfect for clinical trials because you do not have to scale-up — you just run your equipment longer.
Today there is also support from the European side. In 10 years the regulations have become more harmonised, the thinking is more similar and the agencies are working closer together.
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