I’m attending the BioProcessing Network Conference (21-23 Oct 2014) in Melbourne this week. It’s got me thinking about the major changes to biotherapeutics manufacturing. One of these significant changes has come about as a consequence of increased yield; when the quantity of product increases from mg/L to g/L then the scale of manufacturing can be significantly reduced. Instead of requiring a fermenter (or bioreactor) of thousands of litres capacity, it’s possible to work at a much smaller scale. Concurrent with this change has been the use of single use, disposal containers to grow cells, collect harvest and generally to act as sterile receptacles. This has enabled manufacturing facilities to have greater flexibility and a smaller footprint, as they use disposal equipment, rather than extensively relying on fixed stainless steel vessels. Amgen’s new manufacturing site in Singapore captures some of these changes.

These changes also have the advantage that cleaning validation can be eliminated for the disposable equipment and there can be a rapid turn-around of the manufacturing facility to make the next batch. Of course there are also some questions to be answered such as what extractables and leachables may be present in the single use equipment – which are invariably made of some sort of plastic.

Image courtesy of North Sullivan Photography, CSIRO, Preparing Samples of Soy for Testing, Creative Commons 3.0, Disclaimer