Most biopharmaceuticals are produced in batches. And, on the manufacturing line, most unit operations are still discrete rather than continuous. For example, the upstream industry has had the option of perfusion bioreactors since the 1980s, but adoption has been limited.
Eric Langer, from Bioplan Associates, told GEN, “Perfusion technologies have struggled commercially. For example, revenue generated the leading alternating tangential flow (ATF) perfusion systems from leading suppliers is around $20 million, despite having been on the market for 15 years. And in downstream use of continuous processing technologies is minimal.”
But things are changing and the biopharmaceutical industry is showing more of an interest in continuous bioprocessing. According to a Bioplan survey, 70.6% of bioprocessing professionals are testing continuous bioprocessing downstream technologies or considering them, which is an increase from the 68% who said they were looking at such systems in the previous survey.
For René Gantier, PhD, director of technology, gene therapy, at Repligen, increased interest in continuous manufacturing is indicative of willingness to consider innovative, digital biomanufacturing, and bioprocess 4.0 ideas.
“Biomanufacturing 4.0 is its infancy but the advent of continuous bioprocessing, which happened much later than for other industries, will create an opportunity to advance in this direction,” Gantier says. “Biomanufacturing 4.0 will enable the implementation of continuous processing,” he continues, explaining the switch from batch mode requires integrated and automated hardware, advanced in-line analytics using predictive and prescriptive models via multi-variate data analysis.
And the biopharma sector stands to benefit significantly from the greater use of continuous processes, according to Gantier, who tells GEN that the “biopharma industry is driving towards continuous manufacturing to reduce capital investment and operational costs.”
Gantier also cites the ability to reduce time to market and “improve process safety and robustness and subsequently product quality” as potential benefits of the use of continuous processing technologies.
Gradual change is key to overcoming reluctance to embrace innovative technologies, points out Gantier, who says industry conservatism remains.
“The biopharma industry is highly regulated, which makes sense since it relates to people’s health, and this creates a big hurdle to implement new technologies,” he continues. “The technology for biopharma 4.0 is ready, upstream and downstream, to be evaluated and all big biopharma players are evaluating it in R&D. But implementation at pilot scale and commercial manufacturing is facing this conservatism.”
In the end, the benefits, combined with regulatory demand for detailed information about production processes, will outweigh industry reluctance and see biopharmaceutical companies fully embrace bioprocess 4.0, he maintains.
“AI and automation are tools to enable improved version of biomanufacturing,” citing the use of predictive and prescriptive analytics and MVDA models as examples,” Gantier says. “The ability to see any process deviation before it goes out of spec and being able to correct the course automatically will win industry over.”