The general notion regarding autologous manufacturing is that it has huge challenges, points out Parvathi Chandran, senior manager for research strategy and communication at Regrow Biosciences. “But our experience is that you can work backwards, adapting your manufacturing process, and get a consistent cell therapy product,” she says.
Chandran was speaking to GEN about a recent paper in the BioProcessing Journal. This research outlines Regrow’s study of their autologous cartilage cell therapy that was delivered to 115 patients with cartilage defects in the knee.
According to Chandran, the study looked at differences in the starting material—cartilage quantity and quality—and how it affected the manufacturing process and final cell product.
“Because it’s autologous, no two starting materials are the same, so how do you ensure that you have the ideal product?” she says, explaining that patients undergoing autologous cartilage cell implantation can range in age.
Patients may also have had other cartilage treatments, she explains. “Where there’s been multiple interventions, at a certain point, there may no longer be much healthy cartilage tissue.”
The Regrow team says they have adapted the isolation and expansion steps to achieve consistent products independent of the quality and quantity of tissue. According to Chandran, they were able to get good final cell counts, even with small amounts of starting material.
Moreover, she continues, the final cell therapy product had good efficacy. “All the 115 patients we followed up, several years down the line, didn’t need further medical intervention and were able to perform daily activities,” adding that the patient follow-up was not in the published paper.
Regrow has now applied the experience they’ve gained to their epithelial cell therapy manufacturing process, notes Chandran.
“We’ve been able to use our experience by going back to the study to understand what needs to be tweaked in the culture process,” she explains. She also points out that the company has looked at optimizing the composition of the growth media, cell properties, and other parameters.
The cartilage cell therapy used in the study has been approved by India’s Central Drugs Standard Control Organization (CDSCO).