BioProduction Solutions

The production of biologic-based pharmaceuticals is long and complex. Rapid answers from in-process controls confirm your production process is operating as designed—efficiently confirming product quality. With the most comprehensive portfolio of microbiology solutions for bioproduction, bioMérieux, Inc. helps protect your customers, keep you in compliance, and improve your bottom line.

Environmental Monitoring

With 12 weeks minimum dating upon shipment, damage-resistant packaging, LOCKSURE® lids, enhanced neutralization capabilities, resistance to sweating and shrinking, isolator compatibility and flex-temp storage, TSA 3P® can boost your productivity—by allowing you to order larger batches less frequently, cut down on incoming QC, deviations, retesting and paperwork.

Microbial Identification Systems and Services

When investigating the root cause of a contamination, fast, accurate results can make a big difference. To keep your lab running smoothly, all the expertise, robustness, and support you expect from VITEK® is now available in an on demand ID service from the microbiology experts at bioMérieux.

Whether you currently send all samples out for identification or just need to supplement your internal ID methods, VITEK Express delivers quick, accurate results with one fixed price per result. No hassles, no surprises.

Endotoxin Testing and Services

LER can be a confounding issue for manufacturers of biologics. Our ENDOXPERTS™ Endotoxin Services provide routine testing and feasibility studies as well as specialized services for analytical issues such as Low Endotoxin Recovery (LER). Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements. Applying true scientific soundness, we continue our contribution to the deepened knowledge of the LER phenomenon and complex nature of endotoxin.

Based on Recombinant Horseshoe Crab Factor C (rFC), ENDONEXT™ technology is ushering in a new era of smarter, more sustainable pharmaceutical quality control by eliminating the need to harvest horseshoe crab blood and makes your entire lab more efficient with solutions such as ENDOZYME II Go.

Sterility and In-Process Testing

Given the complexity and timelines required to produce biologically-based products, rapid results from in-process monitoring become more and more valuable. Our rapid sterility testing solutions such as SCANRDI® and BACT/ALERT® 3D DUAL-T offer sterility verification results in as little as three hours. Because of its objective method of detection, BACT/ALERT is especially well-suited for products that are non-filterable or turbid by nature.

In addition to automated Rapid Microbial Methods, bioMérieux offers a comprehensive portfolio of traditional sterility methods including a twist on the Media Fill Test: we have developed a dehydrated culture medium containing a unique color indicator which changes color in the presence of contamination.

Quality Control Testing

BIOBALL® contains a precise number of microorganisms in a water soluble ball delivering unprecedented accuracy for Quantitative Microbiological Quality Control.

If you're tired of cultivating and preparing your in-house plant isolates, let us do the work for you. Our method of manufacturing enable you to specify not only the strain of your choice but also the CFU.

Because of its precision, BIOBALL is also well-suited for method validations or spiking studies.

Water Testing

Our versatile endotoxin range, which includes ENDONEXT™, can significantly reduce both hands-on time and time to result when testing water for endotoxins.

Pioneering Diagnostics