1. Advanced Technology
NanoHelix consistently focuses on developing innovative molecular diagnostics technologies and products through constant and intensive investments in R&D. These include innovations such as PMT Technology, Fast Real-time PCR, FMMA (Fluorescence-based multiple melting assay), and our novel POCT NA purification technology. Our pioneering and proprietary technologies can be easily applied to custom diagnostic kits, enhancing performance and providing cutting-edge products.
2. Certified Management and Quality Assurance System
With an ISO 13485:2016 certified system, ICT-based smart factory with GMP facilities, and our dedicated professional staff, we ensure our products’ quality measures up to the highest standard.
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 both customers’ and applicable regulatory requirements. All procedures related to R&D, manufacturing and QC/QA, including raw materials import/inspection, materials and data traceability, delivery , etc., are in compliance with NanoHelix’s certified Management and Quality Assurance system.
3. High production capability
NanoHelix routinely manufactures over 20 various types of enzymes and proteins. We have the capacity to produce more than 100 million units of Taq polymerase each week.
|Product||Production Lot Size||Production Lead Time||Capacity (Year)|
|Taq DNA Polymerase||100 million units||1-2 weeks||5 billion units|
|Hot-start Taq DNA Polymerase||100 million units||2 weeks||2.5 billion units|
|RNase Inhibitor||30 million units||2 weeks||1 billion units|
|Reverse Transcriptase||500 million units||2 weeks||15 billion units|
|Pfu DNA Polymerase||10 million units||2 weeks||100 million units|
|Uracil DNA glycosylase||15 million units||2 weeks||150 million units|
4. Over ten years’ experiences with hundreds of custom developments
As your custom development partner, NanoHelix benefits from many years of experience, resources, and expertise to provide molecular diagnostics enzymes optimized for a wide range of specialist applications.