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GMP-Ready Bulk Enzymes & Master Mixes For Molecular Diagnostics

At Fortis Life Sciences®, we know that effective molecular diagnostic assays require enzymes, reagents, master mixes, and kitted solutions that meet strict quality system requirements produced by experts you can trust.

Knowing what it takes to succeed, we first work with you to understand your specific challenges and then our experts will design, develop, manufacture, and validate complete assay solutions for your molecular diagnostic assay. We operate under the most rigorous requirements of ISO 13485:2016, from early-stage development to tech transfer, scale up, verification, validation, and commercial production.

*Our 21 CFR 820 compliant manufacturing sites are ISO 13485:2016 Certified

We offer custom Enzymes/Reagents, Master Mix Formulations, and Kits for the following applications:

  • Sample Processing
  • PCR & qPCR DNA Amplification
  • RT-qPCR Viral RNA Transcription & cDNA Amplification
  • Isothermal DNA Amplification
  • RT-Isothermal Viral RNA Transcription & cDNA Amplification
  • Next Generation Sequencing
  • CRISPR Editing & Diagnostics
  • Lyo-Ready Products
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Scientist Extracting a Rack Tube With Urine Samples. Closeup of a Scientist Working With Urine Samples in Lab.

All reagents and master mixes are available in:

Custom Bulk Enzyme Development

We offer expertise in the design development and manufacturing of high-quality custom enzymes tailored to your specific applications. Our collaborative process includes data sharing and material transfer to ensure your input is incorporated into the development and quality control of your enzyme.


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Custom Master Mix Formulation

Our in-house experts can help with creating custom master mix formulations for your specific assay. Our collaborative process includes data sharing and material transfer to ensure your input is incorporated into the development and quality control of your master mix formulation.


Contact an expert