Quality control microbiology is the last manual step in modern pharmaceutical manufacturing, and it remains a significant bottleneck between the finished therapy and the patient. Modernizing this step is urgent. It is our mission at Rapid Micro Biosystems.
We have spent decades modernizing pharmaceutical manufacturing. We transformed drug discovery. We automated production. We built global supply chains and the digital systems that underpin them. However, one part of the value chain has not evolved: microbial quality control. This is one of the most consequential steps of unfinished modernization in our industry, and what makes it worse, is the heavy toll it places on patients.
The test that decides whether a finished batch is safe to release to patients still operates the way it did a century ago. A technician places a sample on a petri dish, waits days for colonies to grow, counts them by eye, and transcribes the results by hand on paper and ultimately into a computer. Louis Pasteur, the father of microbiology, would have no problem recognizing this process today.
While we move advanced therapies through state-of-the-art production facilities, our quality control processes have not fundamentally changed since the 19th-century.
A finished therapy waiting in release testing is a patient waiting for treatment. When it comes to many advanced therapy medicinal products (ATMPs), the batch is often developed for one patient and the patient often has run out of therapeutic options. The clock is real and it is ticking loudly.
A quality control system built for a bygone era comes with a cost that the patient cannot afford to bear. That is the part we are not willing to accept, and it is the reason this work cannot wait for a more convenient time.
In addition to being slow, today’s manual testing is also prone to human error, with mistakes related to counting and transcription turning into investigations and lost time. The data integrity of the legacy processes is also weak, making it an area of increased regulatory scrutiny. To make matters worse, the technicians who can run the manual tests are getting harder to find and harder to retain.
When we consider the QC microbiology workflow, we can’t get microorganisms to grow any faster than they did 150 years ago. But, technological advances enable us to “see” microbial growth long before the naked human eye can. This capability is a game-changer made possible by our technology.
We illuminate special cassettes with microbial samples growing on the media surface with blue light, which causes them to faintly glow, a process known as autofluorescence.
To pick up this faint signal, we take pictures every 4 hours using a highly sensitive camera, known as a CCD camera (Charge Coupled Device). Rather than handling hundreds of petri dishes by hand, we rapidly move them to an imaging station with robotic arms. And instead of manually counting microbial colonies and writing the result down in a lab notebook, we use sophisticated software.
Although the core methods that we use for detecting and growing microorganisms are the same methods that Pharma QC labs have relied on for decades, we can deliver highly accurate results to quality control labs much faster than ever before, due to advanced imaging, full automation, and data management.
Today’s advanced therapies demand advanced quality control when it comes to accuracy, turnaround, and patient-centricity. As the rest of manufacturing scales, a quality control step that cannot keep pace stops being a delay – it becomes the constraint.
The technology to fundamentally transform microbial quality control already exists. We pioneered the technology; it is running in GMP production today around the world across a broad array of manufacturing modalities, and it is bringing life-saving therapies to patients much faster than the legacy method it replaces. Automation and AI will do far more in the QC lab than most of the industry assumes, not only producing results but linking insight to action that will positively impact patients.
We work with the majority of FDA-approved CAR-T manufacturing facilities, where we have fully automated a critical legacy testing process. As a result, we have unique visibility into the operational and testing challenges that the rest of the industry is only beginning to recognize. By automating the Micro QC process, we create the capacity needed to scale with growing production volumes, so release testing does not become the bottleneck.
Modernizing quality control is not something that should be deferred to a more convenient future date. It is the last manual step that remains between modern manufacturing and the patient, and it needs to be addressed now. At Rapid Micro Biosystems, we’re providing the necessary technology and capabilities to advance critical microbial quality control infrastructure and stand ready to enable the industry to better serve patients.