Thermo Fisher Scientific’s QualTrak is tailored for biologics development.
Thermo Fisher Scientific’s QualTrak is a comprehensive suite of quantitative polymerase chain reaction (qPCR) tools that includes various Applied Biosystems solutions. The product is tailored for biologics development, including monoclonal antibodies, cell and gene therapies, and vaccines.
Among the solutions in QualTrak are the QuantStudio 6 and 7 Pro-Real Time PCR Systems, as well as the TaqMan and TaqPath master mixes and assays. The TaqPath BactoPure master mix is designed to detect as low as one copy of DNA per microliter from bacterial, viral, fungal, and mammalian sources to ensure contamination-free drug product and accurate titers.
QualTrak comes with readily available compliance documentation to reduce the time needed to comply with internal quality systems and regulatory requirements. To support post-discovery steps, such as manufacturing quality control and biodistribution, all master mixes and assays are manufactured at an ISO 13485-certified, FDA registered facility that uses current good manufacturing practices.