Continuous manufacturing in the pharma industry “is the future,” the US FDA’s CDER Director Janet Woodcock said earlier this month as she pushed for legislation and grants to help encourage drugmakers to make the switch from batch production.
Relatively few companies have embraced continuous manufacturing despite the long-term cost, time and space-saving benefits of such processes, which Woodcock put down to the need for regulatory approval and the high entry costs associated with the shift.
Tim Jamison, a Professor of Chemistry and incoming Department Head at MIT, told in-Pharmatechnologist.com such FDA comments were encouraging, yet he said “there remains a need to develop clear, harmonized guidelines accepted across the various regulatory authorities that will facilitate the development of continuous manufacturing routes in a manner that guarantees a consistent way to monitor/regulate their output.”
A fully continuous manufacturing regulatory route may be approved later this year, Jamison said and this, coupled with the cost and the success of early adopters of the technology will “catalyze the second wave of ‘fast-followers’ that adopt the technology.”
So far only a few pharma firms have invested in continuous processes: GSK is working with the UK Government on such technologies and has invested $29m in a plant in Singapore, Novartis is working on development of systems in collaboration with MIT, and both Vertex Pharmaceuticals and J&J were described as “early adopters” by Jamison.
Lack of Talent
The deeper problem, however, lies in the lack of scientific talent available to lead companies through implementing continuous flow technology at scale, Jamison said.
“It’s not as simple as asking current chemical engineers to start working with continuous flow technology - that is like asking a painter to create a sculpture,” he explained. “Currently, flow chemistry is not a part of course curriculum or training for chemists. Thus, there will continue to be a lack of expertise in this area until this is reversed.”
Jamison, who has launched the company Snapdragon Chemistry to help augment pharma’s access to continuous flow chemistry, told us the problem will eventually be solved, driven by industry's demand.
“As the industry requires more expertise in this area, education/training standards will shift to meet this demand. This, however, will not shift immediately, and there will likely be a short- to mid-term lack of talent.”
Abandoning Current Infrastructure
The transition could also be hampered by pharma’s reluctance to abandon existing manufacturing infrastructure, but Jamison was optimistic drugmakers will look at the benefits of continuous plants when it comes to replacing or upgrading current batch facilities.
“The infrastructure is in various stages of degradation, and new capacity needs to be established naturally. It could be that continuous plants are built in place of new batch plants.
“Moreover, continuous manufacturing plants can be 25-fold smaller in footprint than a batch plant of comparable output. Therefore, the CapEx investment is smaller and it might sway the economic analysis to favor the business case of mothballing a significant number of existing batch-mode plants.”