Vaccine Testing

Microtest supplies high-reliability vaccine testing, helping to demonstrate the safety of these critical biological products. We test both cell banks and virus stocks used in human vaccine production for the presence of adventitious agents.

The Microtest advantage provides vaccine manufacturers with unsurpassed flexibility, customer service, and technical knowledge.

Our vaccine testing programs meet requirements set out in guidance documents from various regulatory agencies. Tests for sterility, mycoplasma, and a number of different virus contaminants help ensure safety. Our in vitro testing detects adventitious agents using MRC-5 cells, Vero cells, and a number of other different cell lines, according to those regulatory guidances.

Microtest offers a range of differently sized culture vessels to accommodate your unique samples. In fact, we can customize our in vitro tests to your specifications. To meet regulatory requirements, our assays are fully validated.

Since your processing cell lines and/or virus seed stocks may at some point have been exposed to animal-derived materials, Microtest additionally offers testing for bovine and porcine viruses. These assays are designed per instructions in the U.S. Code of Federal Regulations, Animals and Animal Products, Title 9 (9 CFR), and deliver recognized Microtest accuracy and reliability.

Many manufacturers face the challenge of testing virus stocks in cell-based assay systems. Microtest can design accurate, efficient testing strategies in concert with your manufacturing experts. If neutralizing antibodies are needed, we can work to qualify the assay systems, ensuring reliable results.

See details on our specific testing:
• Bovine 9 CFR
• Porcine 9 CFR
• In Vitro Testing
• Retrovirus Infectivity Assays
• Custom Assays