A review by Institute for Separation and Process Technology has predicted an increase in the use of single use technologies and continuous processing within the manufacture of biologics in the future.
Researchers Jochen Strube, Reinhard Ditz and Petra Gronemeyer, predict that demands for high quality biologics will continue to increase in the coming decades. Decreasing production and imminent patent expirations of ‘blockbuster’ drugs coupled with a more personalised approach to the production of biologics that goes with stratified medicine, will increase the need for plant flexibility.
‘This trend is likely to advance towards modular facilities. Bioprocessing unit operations can be housed in container-like transportable clean rooms allowing the whole manufacturing process to be transported, constructed and operational within the shortest amount of time. They also have the advantage of possible use in GMP-challenged countries.’
The production of more highly specified biologics in smaller quantities will drive development and innovation of continuous, single-use, and non-chromatographic downstream processing solutions. Demands for high quality biologics will also continue to increase in the coming decades. Integrating upstream and downstream will also assist process optimisation and decrease overall production costs. With regards to already established large-scale plants, Strube’s group states:
‘In terms of capacity, it is most likely that current large facilities (>10,000 L) will remain. New capacities, however, will be added on a lower scale. Other products, for example individualized biologics and personalized medicines, will probably be produced in small scale using single-use technologies due to small required volumes’.
This means a paradigm shift in the way biotechs and pharma companies manufacture their drugs. With a notorious lack of openness to change in the field (particularly due to costs) how long is this change likely to take? Only time will tell. Read the review here.
To discuss the future of the production of biologic drugs upstream and downstream and to hear more about new single-use technologies and developments in continuous processing join us at Cell Culture World Congress and Downstream Processing World Congress in Munich on the 25th and 26th February. If you can’t wait until February come down to our Totalbiopharma meet-up this Tuesday 7th October to discuss this and other biopharma news.