Hzymes help's to get first mRNA vaccine IND approved by the US FDA
Congratulations to Zhejiang Haichang Biotechnology Co., Ltd. for obtaining the approval of the US FDA (IND: 28424) for the IND application of the Novel coronavirus mRNA vaccine booster project, which is the first mRNA vaccine project approved by the US FDA in China.
US FDA
Hzymes Biotech provided high-quality raw materials for the project and worked with Cell and Gene Therapy Innovation Center (CGTIC) of Beijng Tsinghua Industrial R&D Institute (operated and managed by Beijing LotusLake BioMedical Technology), and LotusLake BioMedical provided CDMO services for the project. Since the establishment of the strategic partnership in 2021, Hzymes Biotech has continued to provide high-quality mRNA raw materials and application technical services for LotusLake BioMedical, and assisted in the delivery of multiple batches of gram-level GMP-mRNA stock solution, including working together to help Haichang Bio HC009 The project was approved by the U.S. FDA IND.
Hzymes Biotech has five major technical platforms at the same time, supporting the leading special enzyme R&D and production system; we can provide:
- full range of mRNA raw materials and a variety of mRNA stock solutions, and continue to optimize and upgrade products, and the key indicators of synthetic products are at the leading level
- full-process CRO services from template production, in vitro transcription, capping and tailing, LNP encapsulation, to quality control;
- comprehensive and first-class mRNA quality inspection platforms and supporting methodswith capillary electrophoresis, HPLC, LC-MS and other ;
Hzymes mRNA raw material pipeline:
The case of Spike mRNA LNP
1. mRNA raw
Plasmids with high supercoiled proportions
Note: Pre-digestion plasmid on both sides and post-digestion plasmid in the middle, Marker 10000
optional IVT for Co-transcription method & enzymatic method
- Purity: 87%
- Concentration: 2000ng/ul
- Capping rate: 98.99%
- dsRNA residue: 0.07%
- LNP
- Encapsulation rate: 97%
- Particle size: 87nm
- PDI：<0.1
- Endotoxin: < 10 EU/ml
- Zeta potential: meets clinical requirements
As a high-tech enterprise committed to becoming a “world-class supplier of core enzyme raw material products and services”, Hzymes continues to polish product quality, strive for excellence!