5 Pharmaceutical Quality Control Solutions You’ll Love for your Bioproduction Manufacturing
Today’s pharmaceutical landscape is more vibrant than ever; and while new modalities such as mRNA and an ever-increasing number of biosimilars help make critical vaccines and therapies available to more patients in need, they also put pressure on manufacturers to deliver these drugs safely and cost-effectively.
Although there is no single solution to increasing operational efficiencies and minimizing costs of non-quality, industry experts agree that automating routine analytical testing brings value by reducing costly errors; providing reliable, actionable and traceable data faster; and increasing throughput to reduce bottlenecks.
Monitoring your product and process at key points gives you the confidence that your batch quality is secure. Rapid and automated technologies for both in-process and release testing increase the efficiency of your operations.
Ready to take control of your Quality Control? Let’s start exploring options.
Environmental Monitoring
Environmental monitoring provides critical data to verify your process is meeting specifications, so it is important that you can trust these data.
This is why we have automated and digitalized the entire process with our 3P® ecosystem. Automated reading of 3P® SMART PLATES ensures standardized results faster than manual methods, providing early alerts for out-of-specification samples with end-to-end paperless traceability.
✅ enhanced data integrity
✅ customizable workflows
✅ future-ready solutions
✅ holistic support and training
BONUS: By adding BIOBALL® for your growth promotion testing and the VITEK® MS PRIME for automated microbial identification of colonies, you can bring even more efficiency and data integrity to your EM program.
Mycoplasma Testing
While Mycoplasma contamination in a GMP environment is rare, testing is necessary to ensure product quality. With just two minutes of hands-on time, and results in less than one hour, BIOFIRE® Mycoplasma has revolutionized this formerly complex test.
✅ fast results
✅ simple workflow
✅ secure and efficient
✅ cost savings
Sterility Testing
BACT/ALERT® simplifies sterility testing of cell-based and turbid matrices. The “load and go” system cuts the time of traditional growth-based methods in half; automatically monitoring your sample and alerting you in real time if contamination is present.
✅ validated for product release
✅ approved by regulatory agencies
✅ certified validation services
✅ seamless implementation
If you need sterility or bioburden results within the same shift, SCANRDI® gives you the answers you need within 4 hours; making it a powerful tool for troubleshooting or facilitating investigations.
✅ increased market competitiveness
✅ controlled manufacturing process
✅ more than 200 compatible products
Endotoxin Testing
Environmental monitoring provides critical data to verify your process is meeting specifications, so it is important that you can trust these data.
Our recombinant ENDOZYME® II GO, with pre-coated standards reduces errors, hands-on time and variability of your bacterial endotoxin testing; and offers flexible throughput options ranging from single-sample testing to full automation.
✅ high sensitivity
✅ versatile application
✅ user-friendly
✅ regulatory compliance
Seeking support to address low endotoxin recovery (LER)?
ENDOXPERTS™ offers advanced expertise in endotoxin testing and LER mitigation. The team supports feasibility studies for recombinant Factor C (rFC), develops tailored demasking strategies, and ensures regulatory-compliant workflows for pharmaceuticals, medical devices, biologics, and biosimilars. For biologics, where regulatory demands are especially complex, having expert support can be the key to avoiding delays and ensuring success.
We know that choosing the best diagnostic solution to meet your specific needs isn’t always simple. Our service offer is designed to give you assurance you will get the most from your investment before, during and after implementation.
With more than 60 years of pioneering diagnostics, bioMérieux can be your ally in advancing quality by providing the most comprehensive portfolio of microbiology QC solutions to monitor your products, process and environment.
The result?
Increased Lab Efficiency
Automation & Digitalization
✅ Reduce human error
✅ Reduce retesting
✅ Increase standardization and facilitate training
✅ Optimize workflows
✅ Improve data integrity & traceability
✅ Increase throughput to reduce outsourcing
Decentralized testing
✅ Move in-process testing closer to production
Optimized Production Costs
Reduced cost of non-quality through rapid in-process controls and digitalization
✅ Reduce scrap
✅ Facilitate investigations
✅ Reduce downtime
✅ Optimize human resource utilization
Reduced working capital
✅ Release products to market faster with rapid methods
If you want to improve a quality testing process in your organization, contact us to describe your goal so that together, we can determine and implement the best solution for you.
Featured Solutions
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Bioproduction Solutions Portfolio
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