Applied Biosystems TaqPath assays are the first choice for probe-based qPCR assays that have been specifically designed for late-stage biotechnology and pharmaceutical applications.
These products provide the dependability and performance of TaqMan Assays while also offering the documentation, traceability and compliance required for cGMP manufacturing, process development and regulatory filings.
Controlled manufacturing for lot-to-lot consistency
TaqPath assays have been specifically developed using controlled manufacturing within ISO 13485:2016-certified and FDA-registered facilities and conform to present good manufacturing practices (cGMP), thereby guaranteeing lot-to-lot consistency.
Documentation delivered for ultimate traceability
Users can enjoy improved reagent traceability and compliance support with an extensive documentation package offered with each TaqPath assay. Extra traceability and documentation are proactively offered with every product, such as:
- Lot-specific Certificate of Analysis provided with QC data
- Site QMS certification
- Product statement of quality
- Supply questionnaire
- MSDS for a REACH compliance
- Change notification
- Product stability declaration
- Animal-free origin declaration
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Seamlessly transition assays from discovery through late-stage development
After using a TaqMan Assay to determine a lead compound or biologic at the time of the research and discovery phase, transition to TaqPath assays to help translate those breakthroughs into a therapeutic by offering traceability and consistency.
The portfolio of qPCR assays features more than 21 million custom assays, predesigned assays, and separate custom primers and probes. Such assays are suitable for all qPCR applications, such as microbial detection, copy number analysis, gene expression analysis, miRNA detection and SNP genotyping.
The 11-step, proprietary bioinformatics design pipeline is the gold standard in probe-based chemistry.
All TaqPath assays have been manufactured as per the cGMP principles and are ready for implementation into their process development, clinical testing, QC and manufacturing workflows.
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Flexibility and performance including customization
To offer the flexibility that users require to fulfill their objectives, Thermo Fisher Scientific offers an extensive range of options and tools to help users select and deliver the proper result for their requirements.
Users can easily transition from a present TaqMan assay to a TaqPath assay or enter their primer and probe sequences for a custom TaqPath experience.
Convert current assay
Users can determine any current TaqMan Assay ID and request it as a TaqPath assay (custom or predesigned).
Design new TaqPath probes
Offer a sequence and design a probe with either QSY or MGB quenchers.
Design custom primers
Provide sequences for forward and reverse primers.
Applied Biosystems predesigned TaqMan Assays comprise of target-specific primers and also include one or more probes that have been improved for specific applications, such as SNP genotyping, gene expression, mutation detection, miRNA and copy number variation analysis. It is possible for users to find a predesigned assay or design a custom solution.