Pharma Services
CAR-T cell therapy is a groundbreaking cancer treatment that harnesses a patient’s immune cells to target and destroy cancer.
The decentralized production of these therapies presents an exciting opportunity, requiring rapid and accurate sterility testing to ensure their safety and efficacy before administration to patients.
Background
CAR-T (Chimeric Antigen Receptor T-cell) therapy is a groundbreaking cancer treatment that harnesses the power of a patient’s own immune cells to fight cancer.
This innovative form of immunotherapy involves modifying T-cells to express receptors specific to cancer cells, enabling them to seek out and destroy tumors.
As this treatment becomes increasingly personalized and decentralized, ensuring the sterility of the therapy at every stage of production is critical.
In decentralized manufacturing environments, where CAR-T therapies are produced on-site, there is a pressing need for rapid and reliable sterility testing.
The quick and accurate release of these treatments is vital to ensuring that patients receive the freshest, safest therapies, minimizing delays and reducing the risk of complications.
Enabling Rapid, Accurate Sterility Testing.

miDiagnostics is at the forefront of providing the industry with ultra-rapid PCR-based sterility testing solutions designed to meet the unique demands of CAR-T production.
miDiagnostics is revolutionizing sterility testing with its ultra-rapid, high-performance PCR technology. By adapting our point-of-care PCR platform to the needs of the biopharma industry, we have created a testing solution that significantly reduces the time required for sterility testing, enabling faster decision-making and more efficient production workflows.
Our technology supports fully automated, closed-flow sterility testing, ensuring that CAR-T therapies can be tested for sterility at the point of care, close to the patient. By providing rapid, accurate results, miDiagnostics enables decentralized CAR-T manufacturing platforms to safely release therapies in a fraction of the time compared to traditional testing methods. This rapid response allows for a more efficient supply chain and timely patient treatment.
Key Benefits.

Unique silicon chip technology allowing for ultra-fast PCR

miDiagnostics’ PCR-based tests deliver highly accurate results, ensuring that only safe, sterility-compliant therapies are released. This minimizes the risk of contamination and enhances patient safety.

Our ultra-rapid PCR testing technology reduces the time needed to verify sterility, allowing CAR-T therapies to be delivered to patients more quickly, improving patient outcomes and overall treatment timelines.

The highly accurate PCR technology ensures the highest patient safety.

Seamless Integration
Our technology integrates smoothly with existing CAR-T manufacturing platforms, offering a flexible, scalable solution that fits into decentralized production settings without disrupting workflows.

Improved Manufacturing Efficiency
By automating sterility testing and reducing the time required for batch release, miDiagnostics helps pharmaceutical companies streamline their operations, lower costs, and enhance overall efficiency in CAR-T production.
Ready to learn more about how miDiagnostics can enhance your pharmaceutical manufacturing and testing workflows?
Contact us today to discuss how our advanced solutions can help you deliver safer, more effective treatments to patients.

“miDiagnostics has the potential to disrupt and transform the industry by making diagnostic information available to clinician and patient alike.”
“Its easy-to-use and cost-efficient test will revolutionize point-of-care testing by directly engaging with patients and enabling speedy intervention.”
“Proud to be leading a top team and together with our numerous partners to make a significant contribution to healthcare in general.”
“As a Non-Executive Director on miDiagnostics’ Board, I have been privileged to witness its continued development. I am very proud to see many years of hard work coming to fruition and providing value, facilitating the return to a normal way of life, with potential to move high quality testing closer to the patient.”
“This technology could aid the management of outbreaks in challenging settings, such as nursing homes and home care environments, allowing healthcare professionals to adjust their management decisions at the point of care. ”