Cell and gene therapy manufacturers need data analytics and automated decision making more than robotic pipetting. That’s according to Qasim Rafiq, PhD, senior lecturer and associate professor in cell and gene therapy bioprocessing at University College London (UCL).
“People get caught up thinking about robots but, when I speak to CDMOs [contract development and manufacturing organizations], there’s a far greater need to automate process control and analytics, and you don’t necessarily need robots for that,” he said.
Using automated process control to develop high-quality products is among the projects being pursued at UCL’s Future Targeted Healthcare Manufacturing Hub. Launched in 2016, the Hub is a consortium of industrial partners and governmental organizations, and academic groups led by UCL. Its aim is to investigate the manufacture of future therapeutics by undertaking innovative research and offering industry know-how transfer to students.
The Hub, which is housed in UCL’s Advanced Centre for Biochemical Engineering (ACBE), currently has 35 different users, including big companies like Sartorius and GSK. It maintains a balance between blue-sky projects and solving here-and-now biomanufacturing challenges.
Rafiq’s latest research focuses on a digital control strategy for manufacturing CAR-T cells in stirred-tank bioreactors. Having used stirred-tank bioreactors, a well-understood manufacturing platform, to cut the production time of two billion cells from a week to 3–4 days, Rafiq has moved onto reducing the amount of media required to achieve optimum cell growth. By using a digital controller to feed media into the bioreactor based on the pH, he found it possible to achieve a process intensification of 40–50%.
“Process intensification has a significant impact on costs,” he explained. “If you can cut timelines by half, that has huge cost and resource implications.”
In addition, the process control strategy reduced the timeline and increased by five-fold the yield from poor-growing donor cells. “It does raise some really interesting questions about whether we can adapt manufacturing processes to patient requirements,” he said.
Separately, Rafiq’s team has been funded by the U.K.’s Engineering and Physical Sciences Research Council to develop an “on-body” manufacturing system to reduce the costs of transferring cells from the body to the lab. “That type of project is very high risk,” he says. “We intend to develop a prototype to explore how we’d ensure sterility, and whether we could use blood flow to power the device via a photovoltaic scavenging system.”
Rafiq believes the Hub and ACBE is ahead of its time with only a handful of similar initiatives at universities worldwide. “Out of the top 10 therapeutic products, most are biopharmaceuticals, not pharmaceuticals, so there’s been a shift in modalities, and we think there’ll be even more of a shift in the future,” he noted.