A recent survey by Bain & Company suggests that digital manufacturing is coming to biopharma. The analysts say industry desire for cost reduction and improved product quality are prompting manufacturers to invest in innovative technologies or to seek CDMOs that have done so already.
Biopharma’s digital shift has been a boon for CDMOs, notes Chris Demers, PhD, senior data process scientist, automation at Catalent.
“The bioprocessing 4.0 approach helps CDMOs such as Catalent win business, not because these technologies are selling points themselves, but because automation and process analytical technology (PAT) helps Catalent deliver more consistently higher quality product, which is ultimately what our customers want,” he tells GEN.
“The link between automation and quality holds true across all manufacturing industries. In the automotive industry, Toyota Motor Corporation’s Tahara plant in Japan is a great example of one of the most automated in the world and is famously producing some of the most reliable cars in the industry.”
Cost benefit
The CDMO sector’s willingness to invest in innovative manufacturing technologies reflects a desire to improve the quality of medicines produced on behalf of the biopharmaceutical industry, says Demers.
“There is, of course, cost reduction with bioprocessing 4.0 initiatives, but I would argue that this is only important during the initial buy-in phase at the highest levels. Undeniably, the most important advantage is the direct impact on consistency and quality,” he continues.
“These technologies help get more product out to patients, through increases in titer and reduction in manufacturing deviations, for example. In our industry, every additional vial we can produce is one less person suffering from a life-altering disease.”
Collaboration
The World Economic Forum says that the industries that make best use of digital manufacturing are those that train staff in digital techniques and develop a culture of innovation.
This view is shared by the Manufacturing Leadership Council, which wrote last year that “re-skilling and upskilling the workforce must become business as usual, driven by a culture of learning that permeates the entire organization.”
A similar collaborative, organization-wide approach is needed when adopting digital manufacturing technologies in the CDMO space, maintains Demers.
“Setting up a process with automation and PAT in mind requires significantly more close collaboration between all operational divisions of a CDMO such as Catalent when compared to traditional manufacturing techniques,” he points out.
Demers cites the development of automated processes as an example, explaining, “The proof of concept usually starts in an R&D laboratory, and often automation teams are already involved at that stage, building and testing the code that will be used at scale. This is also the best opportunity for manufacturing operations teams to be involved for training.
“As the technology matures through pilot scale, all other teams are brought on board from regulatory and validation teams to manufacturing sciences—and ultimately this is what can hinder adoption of these new technologies in that it requires broad support and buy-in at an early stage from all teams.”
“In many cases it requires a completely new way of thinking about our manufacturing process, which forces R&D teams to have to ‘sell’ this technology internally—a skill that does not come naturally to most scientists and engineers.”
