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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 Applied Biosystems TaqMan Assays while also providing the traceability, documentation, and compliance needed for process development, cGMP manufacturing, and regulatory filings.
Manufactured under principles of cGMP
Each TaqPath Assay and TaqPath Probe is developed using controlled manufacturing within ISO 13485:2016-certified and FDA-registered facilities that adhere to current good manufacturing practices (cGMP), ensuring lot-to-lot consistency.
Documentation delivered to you for ultimate traceability
Enjoy increased assay 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 to late-stage development and manufacturing
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 proprietary bioinformatics design pipeline for qPCR assays supports a portfolio of over 21 million predesigned assays, custom assays, and individual custom primers and probes. TaqPath assays are ideal for post-discovery qPCR applications, including gene expression analysis, microbial detection, copy number analysis, SNP genotyping, and miRNA detection.
All TaqPath assays are manufactured according to cGMP principles and ready for implementation into your process development, QC, clinical testing, and manufacturing workflows.
TaqPath Assay design and customization
To provide the flexibility you need to meet your objectives, we provide a wide range of options and tools to help you choose and deliver the right outcome for your needs.
Easily transition from an existing TaqMan Assay to a TaqPath Assay or enter your own primer and probes sequences for a custom TaqPath experience.
Frequently asked questions
Q: What if I’m already using a TaqMan Assay as a part of a validated workflow?
A: You can continue to use TaqMan products. However, there are advantages to transitioning to TaqPath products as it provides consistency and rigorous quality standards supported by easily accessible documentation, which is ideal for post-development work.
Q: Why is there a 12-week turnaround time for TaqPath assay and probe products?
A: This timeline ensures that we are able to manufacture and trace each TaqPath product according to cGMP standards. This time allows us to build your TaqPath assay and the associated infrastructure to provide an extra level of traceability and documentation.
Q: What is cGMP?
A: cGMP is a descriptor that indicates the product has been manufactured according to the cited regulation or guideline, such as ISO 13485 or 21 CFR 820. cGMP is not a standard. All TaqPath products are manufactured in accordance with cGMP principles within an ISO 13485 and FDA-registered facility.
Q: Are cGMP reagents and assays necessary for therapeutic development?
A: The use of cGMP reagents and assays is not required by any regulatory bodies. Using cGMP products is an investment to mitigate risks and keep timelines on track during the drug development process.
Q: What unit sizes or scales are available for TaqPath assays?
A: Currently, we only offer large-sized TaqPath products. These provide enough reactions for maintaining continutiy between experiments.
Q: Are all assay IDs from the TaqMan portfolio available as TaqPath assays?
A: Yes. Any TaqMan Assay can be manufactured as a TaqPath assay.
Q: Is there a minimum order quantity (MOQ) for TaqPath assays, primers, and probes?
A: Yes. The minimum order quantity is two units of each large-sized TaqPath assay or probe product.
Q: How do I get my documentation for my TaqPath assay and probe products?
A: Your documentation will be sent to you via email from our Reagent Customs team as soon as it is available. This team will also provide documents such as change notifications and supplier questionnaires upon request.
