Alternative & Cellular Therapies Solutions

Cutting-edge cellular therapy products demand state-of-the-art quality control. Your business requires rapid, accurate results you can trust to ensure product safety and protect consumer health. With a comprehensive portfolio of rapid microbiology testing solutions, bioMérieux, Inc. can help streamline your laboratory workflows, boost efficiency, prevent compliance issues—and ultimately, improve your bottom line.

Environmental Monitoring

A PLATE IS A PLATE, UNLESS IT’S A 3P® PLATE
TSA 3P® was developed specifically for use in clean rooms with environments with enhanced neutralization capabilities, resistance to sweating and shrinking, isolator compatibility and LOCKSURE® lids for sample security. Added features like 12 weeks minimum dating upon shipment, damage-resistant packaging and flex-temp storage add flexibility and can boost productivity by allowing you to order larger batches less frequently, reducing the amount of incoming QC, deviations, retesting and paperwork.

Save time and add ALCOA compliance with rapid growth promotion of your 3P plates with the EVISIGHT® COMPACT intelligent incubator system.

Microbial Identification Systems and Services

MICROBIAL IDENTIFICATIONS YOU CAN TRUST
If you are looking to bring identifications in house, we offer a wide range of automated solutions available with full validation support, including the VITEK® MS system can process 192 samples per run and generate ID results in minutes.

VITEK Express ID Service our latest microbial identification solution, offering a complete identification solution to complement your in-house method. Whether you need to confirm a missed identification or obtain gene sequencing for critical samples, trust VITEK Express for accurate results.

Outsourcing all of your identification to VITEK Express with fixed, no surprises pricing can be a cost-effective way to get the accurate identifications you need.

Endotoxin Testing and Services

COMPLETE ENDOTOXIN SOLUTION
ENDONEXT™ provides reliable results everywhere from in-process controls to final product testing on the most challenging matrices. Whether it’s water or final product testing, ENDOZYME® II GO featuring GOPLATE™—a microplate pre-filled with required standard curve and positive product control concentrations, can reduce handling time by over 50% and produce results in as little as 15 minutes.

Together with ENDOLISA® ENDO-RS enables full quantitative recovery of endotoxin in biopharmaceutical samples affected by Low Endotoxin Recovery (LER) independent of storage time and endotoxin concentration.

Sterility and In-Process Testing

ENSURING PATIENT SAFETY
As cellular therapies cannot wait the full 14 days for traditional sterility testing before they are administered, rapid confirmation of sterility is critical. Rapid Microbiological Methods such as BACT/ALERT® 3D DUAL-T are trusted by numerous cellular therapy companies as a method of safe time-sensitive final product release.

We understand you need for rapid results and can support you from initial feasibility studies thought final validation.

Quality Control Testing

TAKE CONTROL OF YOUR QUALITY CONTROL
With patented, proprietary technology and techniques, BIOBALL® is making quantitative microbiological quality control more accurate and efficient than ever. BIOBALL is effective for a wide range of testing applications – including growth promotion, sterility assurance and method validation.

Plant Isolate is a custom service that manufactures wild-type strains, proprietary strains, or strains from a nominated culture collection at any required CFU.

Automate the reading of growth promotion with the EVISIGHT® COMPACT intelligent incubator system. TSA 3P® + BIOBALL + EVISIGHT COMPACT reduces risks, increases productivity and heightens compliance by adding Data Integrity.

Water Testing

ENHANCED WATER TESTING
The combination of R2A 3P® and the automated intelligent incubator and plate reader, EVISIGHT® COMPACT to reduce errors and increase data integrity for water testing. Streamline the screening of your water for endotoxins with ENDONEXT.

Pioneering Diagnostics