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.
|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.