Background Overview

Recently, the National Key R&D Program “Integration of Biotechnology and Information Technology (BT + IT)” officially launched the key project “Research on Efficient and Stable Sequencing Enzymes and Reagent Systems.” Led by the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, and jointly undertaken by Hzymes Biotech, Qitan Tech, GeneMind Biotech, and Casens Medical, the project focuses on solving the “bottleneck” issues in sequencing enzymes and reagents, providing core support for China’s independent and controllable sequencing technologies. Amid the rapid development of molecular diagnostic technologies, high-quality diagnostic enzymes and efficient protein customization services are the key drivers for industry breakthroughs.

As one of the participants in this key project, Hzymes has been deeply engaged in the biopharmaceutical industry for many years. Leveraging its mature process development capabilities, the company has continued to expand in the fields of molecular diagnostic enzyme R&D and recombinant protein CDMO services, providing partners with end-to-end support from technological innovation to industrial implementation. This enables customers to accelerate product commercialization while injecting critical technological strength into the project’s advancement.

Core Products in Molecular Diagnostics

In the field of molecular diagnostic enzymes, Hzymes has built upon years of technical expertise and independently developed products such as PCR enzymes and reverse transcriptases. These have undergone performance upgrades through process optimization—supported by five major technology platforms: enzyme gene mining, enzyme directed evolution, AI-driven enzyme design, catalytic engineering, and large-scale enzyme manufacturing. These accumulated strengths provide a solid foundation for the development of sequencing enzymes.

Recombinant Protein CDMO Platform

Relying on large-scale recombinant protein manufacturing facilities and a robust production quality management system, Hzymes has extensive experience in developing and producing recombinant protein projects. The company has successfully delivered high-quality products using E. coli intracellular expression systems and Pichia pastoris secretion expression systems, including proteins used in medical aesthetics.

Hzymes provides both GMP-grade and non-GMP large-scale production services, supported by flexible fermentation platforms of 5L–50L–500L–5T–10T–30T–60T, multiple chromatography systems, and freeze-drying equipment of varying scales (0.4㎡–0.5㎡–2㎡–10㎡–20㎡).

A comprehensive quality management system strictly controls production processes and enforces rigorous quality release standards for intermediates and final products, ensuring batch-to-batch consistency and meeting production needs across pilot, mid-scale, and industrial-scale stages.

Conclusion

The launch of this National Key R&D Program project is not only a vital step in advancing the localization of China’s sequencing technologies but also a recognition of Hzymes’ process development capabilities. Looking ahead, we will continue to achieve technological breakthroughs to resolve industry challenges, inject momentum into the high-quality development of the molecular diagnostics and gene sequencing industries, and contribute to realizing the domestic supply of core sequencing enzymes and critical reagents.