Combating Quality Control Challenges and Special Needs of Cell and Gene Therapy Production
In this ‘Experts Interview’ feature published on CELL & GENE THERAPY INSIGHTS, Felix Montero Julian (Healthcare Scientific Director, bioMérieux) and Rey Mali (Vice President Sales and Marketing, Accellix) share their perspectives on current Quality Control challenges and special needs in cell and gene therapy production.
Félix Montero Julian sees the clock ticking. As the Scientific Director of Healthcare Business at bioMérieux, a global leader of in vitro diagnostics, he understands the urgency of cell and gene therapy delivery as a patient’s last line of treatment.
The demand for regenerative medicine is soaring – whether for cancer, sickle cell disease, spinal cord injuries, or bone marrow transplants.“It’s limitless as far as what [these therapies] cantreat,” says Rey Mali, VP Sales and Marketing at Accellix, a manufacturer of a cartridge-based, automated flow cytometry platform. “This is the wave of the future for treatments.”
With so much at stake, quality control testing of manufacturing processes is crucial. With safety testing and quality cellular attribute testing representing 80% of quality control (QC) needs [1], it’s time to ask if QC strategies sufficiently safeguard the accuracy, consistency, and timeliness of cell therapy products.
“Time matters. We need to speed up immunotherapy development and manufacturing. We need to help companies speed up the quality control of these products and make them available to these suffering patients.”
Fortunately, significant advances are supporting development, manufacturing and control of these therapies for patients urgently awaiting treatment. Félix Montero Julian of bioMérieux and Rey Mali of Accellix teamed up in 2020 with the same end goal: to streamline QC testing – safety and cellular attribute analysis – with a more comprehensive workflow to accelerate production and control of cell and gene therapies. This partnership works with cell and gene therapy manufacturers to:
1. Improve manufacturing processes by providing on-site, automated, and rapid testing to deliver actionable results with reduced hands-on time
2. Reduce the cost of QC to make these therapies more accessible
3. Ensure any cell or gene therapy that is administered to a patient is safe, effective and meets a pre-defined set of quality parameters.
HOW DOES SLOW TURNAROUND TIME AFFECT C> PRODUCTION AND THEIR PATIENTS?
RM: The cell and gene therapy manufacturing process takes anywhere between 2 to 4 weeks, on average. As new research and trials roll out, the time is gradually getting shorter. But the patient is still waiting three weeks to a month, from the point they give their blood to the point that they receive their therapy infused. During that manufacturing process, there are many, many different QC checkpoints that verify: Is the process proceeding as planned? Can we infuse the cells into the patient? Does the batch have the right population of cells? Did the cells get modified correctly?
FMJ: Most microbiological techniques still rely on compendial methods in which samples are placed in culture broth media. By nature, these kinds of cultures take time. Sterility testing requires 14 days, as regulated by pharmacopeia. We cannot afford to wait 14 days to have results on these products because it’s wasting time for the patients. Thankfully,we have the technologies to detect micro presence in the samples in a few days, as opposed to 14 days. Some technologies deliver results in 5 to 7 days using growth-based methods.
