Reliability

Why NanoHelix?

1. Advanced Technology

Due to constant and intensive investment in R&D, NanoHelix develops its own innovative technologies and products for molecular diagnostics; PMT Technology, Fast Real-time PCR, FMMA (Fluorescence-based multiple melting assay), novel POCT NA purification technology (Punch-it™ NA-Sample Kit) etc. These novel and proprietary technologies could be easily applied to the custom diagnostic kits to enhance their performances and develop cutting-edge products.

2. Certified Management and Quality Assurance System

ISO 13485:2016 certified management and quality assurance system, combined with our dedicated professional staff, ensure our products' quality which measures up to the highest standards. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices (including in-vitro diagnostic products) and related services that consistently meet customer and applicable regulatory requirements. All of the procedures related to R&D, manufacturing and QC/QA, including raw material import/inspection, material and data traceability, delivery etc., are following the certified Nanohelix’s Management and Quality Assurance system.

3. High production capability

NanoHelix manufactures +20 different enzymes and proteins routinely. More than 30 million units of Taq polymerase are produced in a week. The current annual production capacity of Taq polymerase is about 1.5 billion units.

Annual production capacities of main enzymes.
Product Production Lot Size Production Lead Time Capacity (Year)
Taq DNA Polymerase 35 million units 2-3 weeks 1.5 billion units
Hot-start Taq DNA Polymerase 25 million units 2 weeks 1 billion units
RNase Inhibitor 10 million units 2 weeks 200 million units
Reverse Transcriptase 1 billion units 2-3 weeks 10 billion units
Pfu DNA Polymerase 10 million units 2 weeks 100 million units
Uracil DNA glycosylase 5 million units 2 weeks 50 million units

4. Over 10 years’ experiences with hundreds of custom developments

As your custom development partner, NanoHelix leverages over 10 years’ experiences, resources, and expertise to provide molecular diagnostic enzymes optimized for a wide range of specialist applications.

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