Hongene Biotech Corporation

Overview

Hongene Biotech Corporation is a specialized CDMO focused on nucleic acid manufacturing, with nearly 30 years of RNA-focused expertise. The company operates a vertically-integrated platform spanning raw materials production through advanced CDMO services, reducing handoffs and accelerating timelines for oligonucleotide and mRNA therapeutic programs.

Core Services

Oligonucleotide CDMO

• Process and analytical development with chemoenzymatic ligation technology for high-purity, scalable siRNA, sgRNA, and other oligonucleotides
• GMP production up to tonne scale
• Quality control, regulatory support, and release testing

mRNA CDMO

• Plasmid DNA template generation and linearization
• One-pot in vitro transcription (IVT) with integrated plasmid linearization
• Capping with proprietary HiXCap™ technology for improved translation efficiency
• Purification and QC (≥98% full-length, dsRNA <0.01%)
• LNP formulation, lyophilization, and aseptic fill–finish

Custom Synthesis

• Tailored nucleotides, phosphoramidites, linkers, and specialty reagents
• Portfolio of over 2,000 SKUs including phosphoramidites, GalNAc conjugates, linkers, NTPs, cap analogs, and enzymes
• Rapid turnaround for bespoke requests

Technical Capabilities

Development Services

• CMC: Process development & optimization, formulation development, non-GMP and GMP batches, FTE model
• Analytical: Method development & validation, impurity profiling, raw material and intermediate testing, ICH stability testing, release testing
• Commercial Manufacturing: Process Performance Qualification (PPQ), GMP manufacturing trains, global regulatory filing support (CDE/FDA/EMA)

Raw Materials Manufacturing

• In-house manufacture of all key building blocks at commercial scale
• World-leading production capacity for phosphoramidites, GalNAc conjugates, linkers, NTPs, cap analogs, and enzymes

Differentiation

Hongene leverages proprietary technologies including chemoenzymatic ligation for scalable oligonucleotide synthesis and HiXCap™ for cost-effective mRNA optimization. The company is an ACS Green Chemistry Institute member, pioneering solvent recycling and enzymatic synthesis to reduce environmental impact. Vertically-integrated operations ensure regulatory alignment and quality control across the entire value chain from discovery through commercial manufacturing.