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Applied Biosystems TaqPath general purpose reagents are designed to enable confidence and reliability for even your most demanding applications in molecular diagnostics testing, assay development, and biopharma quality control testing. TaqPath probe-based real-time PCR (qPCR) master mixes enable high levels of consistency and reliability with features including stringent cGMP manufacturing, proven performance, and compliance documentation support. Leverage the features and benefits of TaqPath real-time PCR master mixes to help simplify regulatory submissions for IVD assay development and biopharmaceutical quality control testing.
TaqPath qPCR master mixes are developed using stringent manufacturing and lot release criteria to help ensure lot-to-lot consistency for reproducible and reliable results. As shown in the figure, TaqPath qPCR reagents demonstrate excellent Ct concordance and reliable uniformity between lots. Customers can be confident that TaqPath reagents deliver consistent levels of performance and accuracy, thereby reducing the need for revalidation, minimizing the risk of experimental errors, supporting compliance with regulatory requirements, and contributing to cost-effectiveness.
The exceptional lot-to-lot consistency of TaqPath master mixes is facilitated by stringent manufacturing processes and rigorous analytical and functional quality control testing. TaqPath master mixes are manufactured in an ISO 13485-certified and FDA-registered facility that adheres to cGMP principles. Each lot produced is subjected to rigorous analytical and functional quality control testing. A description of the quality control tests performed and the release criteria for those tests are available on each TaqPath master mix product page within the lot-specific Certificate of Analysis document.
Unlike other master mixes on the market, TaqPath master mixes have a proprietary formulation that allows robust performance even in the presence of PCR inhibitors typically found in biopharmaceutical, molecular diagnostics, and research applications.
Optimized performance in the presence of such substances that can normally inhibit PCR, such as heparin, hematin, or EDTA, helps increase confidence when working with a variety of complex clinical or biopharma samples. In a comparison study, only the TaqPath master mix demonstrated no measurable Ct shift from baseline in the presence inhibitors, indicating more robust inhibitor tolerance compared to competitor reagents.
TaqPath master mixes include formulations optimized for multiplexing, allowing for additional targets and/or controls to be run simultaneously for efficiency or quality control purposes. To enable multiplexing assay design flexibility, TaqPath master mixes are available with a passive reference (ROX or Mustang Purple depending on the mix) and are also available without a passive reference, which allows for an additional target to be interrogated. See our TaqPath master mix seletion chart for the options available for your desired application(s).
To facilitate a continuous and reliable supply of our TaqPath master mixes, Thermo Fisher Scientific has expanded its manufacturing capabilities, which include the manufacture of TaqPath products in multiple locations. By doing so, we aim to minimize potential disruptions caused by unforeseen events such as natural disasters. This emphasis on supply chain assurance enables us to limit manufacturing and delivery interruptions in order to support scientific research and innovation with a reliable supply of TaqPath master mixes worldwide.
TaqPath real-time qPCR reagents include readily available compliance documentation and support to alleviate compliance headaches associated with the regulatory submission process. Self-serve compliance documentation is easily accessible on the product web pages to efficiently support your compliance documentation needs.
We acknowledge how important product consistency is to our customers and although we rarely make changes to our products, we strive to provide you with an advanced notice should they occur. By completing a one-click web sign-up for change control for TaqPath reagents, you can be e-mailed in advance prior to implementation of major changes that may affect the form, fit, or function of the product.
TaqPath master mixes are general purpose reagents labeled ‘For Laboratory Use.’