Cell & Gene Therapy Testing
RAPID RESULTS YOU CAN TRUST
Cutting-edge cellular therapy products demand state-of-the-art quality control. Discover our fully-automated, ultra-sensitive testing solutions with very short TTR .
Comprehensive Quality Testing Solutions
With a comprehensive portfolio of rapid microbiology testing solutions, we can help streamline your laboratory workflows, boost efficiency, and prevent compliance issues. See how you can optimize the manufacturing of your cell and gene therapies, and ensure patient safety with our comprehensive range of systems and smart quality testing solutions.
3P Environmental Monitoring
Imagine a fully digitalized Environmental Monitoring (EM) process where your data is totally under your control and accessible in real-time.
AIR IDEAL® 3P® Powerful Air Testing
AIR IDEAL® 3P® is used for the detection of viable organisms through active air sampling. It uses standard prepared media, including contact plates and 100mm plates.
BACT/ALERT® 3D
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.
ENDONEXT™
ENDONEXT™ endotoxin detection assays are ushering in a new era of smarter, more sustainable pharmaceutical quality control.
VITEK® MS PRIME MALDI-TOF Mass Spectrometry System
The VITEK® MS PRIME is an innovative MALDI-TOF mass spectrometry system that takes your automated identification experience to the next level.
Discover More Resources
ON-DEMAND: BACT/ALERT® 3D: FROM ALTERNATIVE TO ROUTINE FOR TESTING CELL AND GENE THERAPY PRODUCTS
Listen to Lori Daane, Sr. Director of Scientific Affairs at bioMérieux, discuss rapid sterility testing within the cell and gene therapy landscape. She discusses the evolving regulations and why the BACT/ALERT® has continued to be the go-to instrument of choice for testing these products for microbial contamination.
CUTIBACTERIUM ACNES GRAM POSITIVE BACTERIA CAUSING INFECTION
Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne. Acne is one of the most common skin diseases, affecting more than 45 million individuals in the United States.
RAPID STERILITY TESTING OF GENE AND CELL THERAPY PRODUCTS
Gene and cell therapy products, also known as advanced therapy medicinal products (ATMP), present unique challenges for Quality Control release testing due to their very short shelf life, fast medical need for dosing patients, and limited availability of product for sterility testing. As such, meeting the requirements for existing compendial sterility test methods is often difficult, if not impossible, to achieve.