Product/Service

TaqPath Assays And Probes

Source: Applied Biosystems by Thermo Fisher Scientific, qPCR
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Applied Biosystems TaqPath assays are the industry-leading choice for probe-based qPCR assays for late-stage pharmaceutical and biotechnology applications. These products offer the reliability and performance of TaqMan Assays while also providing the traceability, documentation, and compliance needed for process development, cGMP manufacturing, and regulatory filings.

Controlled manufacturing for lot-to-lot consistency

TaqPath assays are developed using controlled manufacturing within ISO 13485:2016-certified and FDA-registered facilities and adhere to current good manufacturing practices (cGMP), ensuring lot-to-lot consistency.

Documentation delivered to you for ultimate traceability

Enjoy increased reagent traceability and compliance support with a comprehensive documentation package provided with each TaqPath assay. Additional traceability and documentation are proactively delivered with each product, including:

  • Lot-specific Certificate of Analysis with QC data
  • Site QMS certification
  • Product Stability Declaration
  • Animal-free Origin Declaration
  • Product Statement of Quality
  • Change notification
  • Supply questionnaire
  • MSDS for REACH compliance

Seamlessly transition assays from discovery through late-stage development

After using a TaqMan Assay to identify a lead compound or biologic during the research and discovery phase, transition to TaqPath assays to help translate those discoveries into a therapeutic by providing consistency and traceability.
 
Our portfolio of qPCR assays features over 21 million predesigned assays, custom assays, and individual custom primers and probes. These assays are appropriate for all qPCR applications, including gene expression analysis, microbial detection, copy number analysis, SNP genotyping, and miRNA detection. Our 11-step, proprietary bioinformatics design pipeline is the gold-standard in probe-based chemistry.
 
All TaqPath assays are manufactured according to cGMP principles and ready for implementation into your process development, QC, clinical testing, and manufacturing workflows.