It’s no surprise that cell therapy companies face a myriad of hurdles when developing a product from bench to bedside.
The range of challenges can sometimes feel overwhelming – even for the most seasoned pros in regenerative medicine. So we set out to ask some of the leading names in the industry what some of the biggest hurdles are, and what can be done to overcome them.
Aby Mathew Ph.D., Senior Vice President and CTO, BioLife Solutions.
Aby believes one of the biggest challenges is that companies set up their processes for clinical feasibility, not necessarily commercial viability. ‘So they’re focused on, does the therapy work, not necessarily can we scale it up, can we make it economically viable, can we deliver it globally?’ Aby says.
So what’s the solution? Aby believes it’s down to human capital and mass manufacturing: ‘Down the road, what they might look to do is automate their processes, so instead of having a manufacturing process that might take 50 or 100 people, they might be able to implement a machine that can reduce the head count, but can also reduce the possibility of human error.’
Another solution, Aby says, is to buy in bulk. ‘In the manufacturing process, things such as media components, instruments that you have to use, or components where its packaged up, all of those end up adding to the individual cost. But when you go and buy that from your suppliers, you’re going to get a much better price if you order 1,000 units rather than 10 units and that’s really where that scale-up starts showing the cost of goods benefit.’
Jon Rowley, Ph.D., Chief Executive and Technology Officer, RoosterBio, Inc.
Jon Rowley agrees. He believes a big challenge that many companies have is being able to manufacture products at commercially relevant lot sizes while maintaining all the quality parameters of the cells. ‘They need to make sure that those stem cells don’t lose the biological functionality that they have that makes them therapeutic in the first place. And during scale-up, this can definitely be lost if you’re not looking at the right things,’ Jon says.
His solution? Jon says companies need to understand what the quality parameters are, get the technologies in place to manufacture at a much larger scale, and then manufacture these cell therapy products at costs that enable companies to go to market with them and actually have a profit left over at the end of the day.
Julie G. Allickson, Ph.D., Director, Regenerative Medicine Clinical Center, Wake Forest Institute for Regenerative Medicine
Julie Allickson notes that regulation and due process can pose a challenge to many companies. She advises, “moving to regulatory approval in an efficient manner means really early discussions with the FDA, being able to share with them your knowledge in regards to the technology, and to be able to get their input.” She adds there are several opportunities to talk to the FDA along the way that companies should take advantage of in order to make the process run as smoothly as possible.
Discover more technical and commercial strategies to deliver cell and gene therapy products to patients at the Cell Therapy Manufacturing & Gene Therapy Congress. View the agenda and buy tickets here: https://celltherapy.knnlab.com/