Autologous therapy developers should consider “turnkey” manufacturing systems and robotic arms to minimize costs and manual handling, says an expert.
The medical benefits of patient-specific, autologous cell therapies are proven according to Greg Russotti, Century Therapeutics’ CTO who told BPI West attendees the challenge now is reducing the cost of making such products.
“Autologous [therapies] are proven to make major differences in patients’ lives. And, you know, no one can say they’re cures yet, but in some cases they are getting there.”
Image: iStock/Natali_Mis
Scalability is the major hurdle – Russotti said – explaining that, unlike allogeneic therapies, autologous therapies are difficult to produce at large scale which means keeping the cost of goods sold (COGS) high.
“A big challenge for autologous is that every patient is different, so the starting material for every patient is different. With donor derived and IPSC derived, you have more control.”
He continued: “I think the big difference is that for autologous you’re mainly looking at scale out, whereas for allogeneic you’re looking at scale up.
“And when I say scale out, the reason is, you can only make a batch for a patient at a time you can’t combine patients when you’re doing autologous every patient has his or her own starting material.”
Turnkey solutions
To overcome these issues, developers will need to focus on manufacturing methods and technologies, according to Russotti, who cited minimization of manual handling steps as a major area of activity.
“Some companies are moving towards what we call these ‘turnkey systems’ where they’re fully automated. The vision with these types of systems is that you put new material in your program that your process to run a certain way, and you walk away and you come back and the product is ready. So that’s the idea: very few manual steps.”
One potential challenge for firms using turnkey technologies is the need to ensure production processes are compatible Russotti said.
“If you already have a process in mind, or even worse, you have a process already running for clinical trials, you might have certain unit operations you’re using that may not be compatible. And that might mean a big change for your process.”
Rise of the robots
In such circumstances, robot-based automation is an option.
“So then another solution would be to replace manual labor with robotic arms. And here the thought is if you already have a process running in the clinic… you really could use robotic arms for many of the typical steps.”
He cited culture and sampling methods as well as in process measurements as examples where robotic arms could be applied to help minimize manual handling, thereby reducing costs.
“This would mean a shift in workforce from manual labor to more automation type expertise. But that would probably mean a reduction in workforce, which obviously is a really good thing.”
He added, “if you remove people, you’re going to remove mistakes, you’re going to remove the human error, consistency would be better because I would think a robot would pipette similarly and move things around similarly every time and this would lead to lower cost of goods.”