Matthew Lehman, CEO of Prima, told BioPharma-Rerporter.com in an exclusive interview that the production of a personalized treatment like CVac, which is the company’s lead product, presents “a number of manufacturing challenges” as the company looks to scale up to a commercial offering.
Prima has to ensure “everything from how to collect cells from patients, how to automate scheduling, labelling the cells, how to ship those frozen materials, to how the actual process of making the product in the lab works,” Lehman said. This is a process done in three sites in Australia, US, and Germany, which is the company’s flagship site.
The manufacturing process is a combination of semi-automated cell separation and characterization and mostly single use bags for cell culture, Lehman explained. “The cells are in single-use bags and automated separation and culture the cells in single-use bags and then semi-automated steps for washing the cells at the end of the process and then fill and finish,” he added.
The first time the product was made was 12 years ago, and for several years it was all done at a single site in Melbourne, Australia, and then the company began scaling up in 2009.
CVac is a personalized immunocellular therapeutic under investigation for the treatment of epithelial ovarian cancer. The CVac treatment is a targeted cancer immunocellular therapeutic that stimulates the patient‘s own immune system to target and destroy tumors.
Lehman noted that the manufacturing platform could be applied to other developing biologics. There are “a number of applications for this immunocellular manufacturing platform and we’ve done a lot of work on this for years – other companies and groups could benefit from this product development process as it’s not just a process of taking and manipulating cells,” he added.
The company is now beginning a larger Phase II trial that will begin “in a matter of weeks,” Lehman noted. The company will investigate the possibility of more trials over the next two years “as we continue to scale up manufacturing,” he said.