By Rick Morris, Senior Vice President of Research and Development, Pall Biotech
There have been many changes in biomanufacturing over the years. Admittedly, none of the changes have been “revolutionary” in nature; rather they have materialized because of a shifting market landscape. In fact, the basic building blocks or unit operations of biomanufacturing processes of today are not substantially different from those developed over 20 years ago.
Of the many changes that have occurred in bioprocessing, the rise of single-use is one of the biggest.After single-use, where does the industry go next? It is time for bioprocessing to further evolve .At the start of this article, I admitted that the batch process is at least effective – it gets the job done. But I also shared concerns about a lack of efficiency. It is well accepted in other manufacturing industries that continuous manufacturing is far more efficient. In the small molecule world, pharma companies are adopting continuous processing – mostly in the conversion of API to drug product (the API is continually blended with excipients, and converted into tablets). Continuous bioprocessing is also starting to emerge – here, we are talking about a continuous chain from the bioreactor to the drug substance. It is a natural evolution for bioprocessing.