One-quarter of globally approved cell and gene therapies today are customers of the Growth Direct® System.* While this impressive statistic is tempered by the small number of therapies currently available to patients, a rising wave of new and highly complex therapeutic modalities is on the verge of making efficient, automated quality control (QC) microbiology more important than ever before.
It’s estimated that as many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023, according to Alliance for Regenerative Medicine CEO Timothy Hunt, with possible FDA approval of 10-20 new therapies a year by 2025. Also in the pipeline, Hunt notes, are over 2,000 clinical trials with 200 in the Phase III stage.
This wave of new, life-altering therapies offers the potential to reduce the burden of chronic diseases worldwide. But the complex, multi-step processes required go well beyond the limits of traditional biologic drug manufacturing, demanding higher QC testing intensity per batch for firms under severe pressure to achieve successful commercialization.
Robust Automation that Supports Scale-Up
If your specialty is CAR-T cell therapy, for example, the challenge of infusing genetically modified immune cells into patients entails mountains of data and large numbers of highly skilled personnel, to say nothing of more opportunities for contamination. Traditional compendial methods simply cannot keep up with these requirements, given the compressed vein-to-vein timeframes.
For one cell therapy leader, automating colony counting with the Growth Direct® System helped to address several pressing issues:
- Ever-increasing demands for greater production capacity, particularly in the volume of microbial environmental monitoring (EM) samples as the number of patient lots increases
- Time-consuming microbial EM quality control processes, tying up valued lab personnel with manual steps such as subjective enumeration, verification, and error-prone record keeping
- Potential data integrity issues with manual processes
- Ability to integrate with existing laboratory information management systems (LIMS)
For one CAR-T leader, QC automation helped reduce detection time of microorganisms across an eight-company user group.
As documented in a recent RMB webinar, the company was able to reduce detection time of microorganisms while still meeting exacting quality requirements. Equally important, the Growth Direct® System supported a modular approach spanning not one but eight of the company’s manufacturing sites – combining definitions from USP<1223> and PDA TR33 for relatively swift validation as an automated compendial test.
To hear more about this validation experience in the company’s own words, check out our 14-minute webinar.
A Huge Advantage for Patients, Manufacturers, and Staff
“Taking away the human aspect and letting robotics take over is a huge advantage,” noted industry QA/QC expert Irving Ford during his exclusive interview with Rapid Micro Biosystems. “Currently, most cell therapy treatments are either the third or fourth line of defense. If the patient is getting this treatment, it’s often their last hope for survival. So, clinicians want the therapy back as soon as they can get it. If a company had to wait on traditional micro testing, it would only add to the time it takes to get it back to the patient.”
Another key motivation is the ability to have a completely paperless laboratory, supported by the Growth Direct® System’s proven connectivity and LIMS integration. “Each process is segregated, and you can have up to 20 batch records for one active cell therapy process,” Ford said. “You can just imagine that if all of those records are paper, you’ve created this mound of paper you have to track, review, and verify. That is not sustainable.”
Staff training, productivity, and retention, already challenging in busy QC Micro labs, are particularly urgent when batch loss due to contamination is literally a matter of life and death. While errors are relatively rare, pressures can lead to employee anxiety, burnout, and turnover that negatively impact commercial viability. The human impact in this high-stakes environment cannot be overlooked – but it can be eased via automation.
The Industry Leading Platform for Evolving QC Burdens
Already chosen by over half of the top 20 global pharma companies, the Growth Direct® System also makes it possible to automate compendial methods and streamline data integrity practices for tomorrow’s wave of cell and gene therapy products, as well as other advanced therapeutic medicinal products. To learn more, check out our cell and gene therapy whitepaper. Or feel free to contact Rapid Micro Biosystems today.
*Internal data on file
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