Cell and gene therapy manufacturers are increasingly focusing on quality control (QC) as more products enter Phase I and II clinical trials. That’s according to Felix Montero-Julian, PhD, scientific affairs director at bioMérieux, who gave a talk on QC testing platforms at BioProcess International US West earlier this year.

“At the beginning, QC is less of a constraint,” he explains. “However, as you go into Phase I and Phase II, you need more control, and by the time you reach the final release of a regulated product, you need a very good QC methodology.”

Montero-Julian likens QC in the gene and cell therapy industry to a plane that’s being built while it’s in the air. “We are still improving our processes because manufacturing for autologous and allogeneic therapies have a range of different QC needs, and the specific platforms have different requirements depending on the processes they have,” he continues.

bioMérieux offer the BIOFIRE® Mycoplasma, an instrument and reagent kit for testing for mycoplasma contamination, and BACT/ALERT® 3D DUAL-T for rapid sterility testing. The company claims these systems are fast, fully automated and simple to use and, according to Montero-Julian, increasingly popular with cell and gene therapy companies.

“They reduce the lead times to manufacture these products, which means they can increase capacity and have a more rapid response to contamination incidents,” he says, adding that improvements in QC technology can have a large impact on the value of cell and gene therapies as the cost of individual batches is relatively high.

Montero-Julian explains that the bioMérieux instruments were originally designed for general biomanufacturing, where mycoplasma contamination can affect cell culture yields. However, as he explains, mycoplasma contamination of cells used in cell therapy can adversely affect the health of patients.

Speaking about the nuances of developing QC processes for gene and cell therapy, Montero-Julian points out that allogeneic therapies tend to require more stringent viral testing as donor cells will be introduced into multiple patients. In contrast, viruses in cells taken from a patient for autologous therapies may be less likely to harm the patient when the cells are re-infused.

“The technologies could be the same [for autologous and allogeneic therapies],” he says. “But what’s interesting is there might be different QC panels.”



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