Routine continuous bioprocessing up to ten years away
Watson-Marlow published a report suggesting that 45% of respondents from US and 33.3% from Western Europe expressed a need for better downstream continuous bioprocessing technologies.
Further than this, a survey of biomanufacturers found that 37.3% were planning to trial continual chromatography in their facilities in the following year.
Overall, 20% of senior executives questioned stated that improvements to upstream and downstream manufacturing are a consistent concern to the industry.
Benefits of continuous
The report posits that continuous bioprocessing could offer such an improvement to bioprocessing through reduced downtime between production lots therefore increasing productivity.
As a result of a switch to continuous production, the equipment itself can also be downsized, such as through the use of smaller bioreactors, allowing for the size of facilities to be reduced, as well as by removing the need for storage tanks to hold material in between processing steps.
In addition, though a fully continuous process is possible, companies can also look to create a hybrid approach, as Pall Biotech explained in a recent interview.
Unlike batch production, the processes will run for far longer, sometimes up to 90 days, which allows for greater intervals between changing equipment, though this can raise issues of itself.
Hurdles to overcome
One such issue, the report suggests, is maintaining the sterility of the equipment. This burden is partially alleviated by the widespread adoption of single-use technology.
However, the systems will have to be created specifically for the continuous conditions, which include high flow rates and pressure for hundreds of hours at a time.
The report notes that this has caused some concern among manufacturers about extractables and leachables – chemicals that transfer from the single-use container into the process solution. This places additional pressures on manufacturers of the equipment to ensure the extractable/leachable profile is risk assessed.
A further issue is the number of different systems that could end up being connected. The report states that “the multiple process systems, typically supplied by different vendors and operating at different flow rates and pressures, which need to be connected together in an integrated fashion.”
In turn, once productivity is increased at the upstream stage, downstream activities will also need to be altered to cope with the additional demand.
The future of continuous
Despite these challenges, a number of companies are now trialing systems for continuous bioprocessing.
Last year, Fujifilm Diosynth Biotechnologies created a site in the UK that utilizes a single piece of equipment to operate production runs, mitigating any challenge posed by running a system with different vendors’ equipment.
Sanofi also announced, late last year, that it had opened a US facility running continuous bioprocessing, with the intention to roll out similar facilities across the rest of its network.
Though these companies are running continuous bioprocesses now, Watson-Marlow’s report still concludes that although ‘dramatic progress’ has been made, it estimates that it will take another five to 10 years before a fully integrated approach is routinely taken at commercial scale.