Do Your Cellular Therapies Have High Performance Quality Control?
Overcoming complex manufacturing challenges and ensuring the quality, safety, and efficacy of cell and gene therapies administered to patients is critical.
Your innovative products demand trusted testing systems.
Add rapid and easy-to-use technologies to your operations and bring overall efficiencies to the manufacturing process through both simplified workflows and accurate, actionable results to ensure patient safety.
There’s no time to lose when a patient relies on your product. Streamlined Quality Control testing specific to cell and gene therapies yields safe, rapid, and efficient results.
Discover the bioMérieux’s proven portfolio of value-added solutions.
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Monitoring quality in microbiology is critical and challenging for pharmaceutical companies. While hand transcription remains the standard procedure in use, these daily processes often rhyme with errors leading to time-consuming investigations, and not fully compliant data.
Environmental monitoring (EM) is the main microbiological control performed by pharmaceutical industries. While multiple hand-written and transcription operations remain the standard procedure in use for thousands of samples per month, the daily processes often result in errors leading to time-consuming investigations, low value-added tasks and data that is not fully compliant. As a result: major impacts on batch release, on process efficiency and ultimately patient safety.
3P® SMART PLATES
The 3P® legacy is one of delivering proven performance when it comes to effective pharmaceutical contamination control. Now it’s going digital.
AIR IDEAL® 3P®
AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling.
API® makes microbial identification simple and reliable. Combining a standardized method with an extensive and robust digital microbial ID knowledge base, API® can easily be implemented into any microbiology laboratory.
The BACT/ALERT® 3D was developed as an effective and safe solution for industrial sterility testing.
BIOBALL® Standardized Strains
BIOBALL® is a small water-soluble ball containing a precise number of microorganisms that delivers accuracy and precision, batch after batch.
BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.
The phenomenon of Low Endotoxin Recovery (LER) has gained renewed attention in the scientific community in recent years as the FDA now requires that all new Biological License Applications are able to successfully unmask when LER occurs. ENDOXPERTS™ is our solution for unmasking LER, which helps you meet regulatory requirements.