Yeasen Biotechnology has officially received confirmation from the U.S. Food and Drug Administration (FDA): our UltraAAV PEI Transfection Reagent–GMP grade has been accepted into the FDA’s Drug Master File (DMF) system and granted a DMF number.
What Does This Mean for You?
When you select Yeasen’s products for your drug development projects and prepare regulatory submissions to the FDA, you can directly reference our DMF. This eliminates the need to submit detailed information about raw materials and excipients, significantly streamlining the regulatory review process. Ultimately, it accelerates approvals and shortens the time to market—helping your pipeline move from bench to bedside faster.
About UltraAAV Transfection Reagent
Hieff TransTM UltraAAV Transfection Reagent–GMP is specifically designed for large-scale recombinant AAV production in suspension 293 cell systems. It consistently delivers:
- Highest Viral Titers
- Doubled Full Capsid Ratios
- Broad Compatibility across AAV serotypes (AAV2/5/6/8/9) and multiple commercial or in-house adapted 293 suspension cell lines and media systems.
This reagent offers robust and scalable performance for gene therapy research and manufacturing, enabling seamless transition from laboratory development to clinical application.
Innovation-Driven Manufacturing
Yeasen transforms R&D strength into end-to-end manufacturing capabilities through a fully vertically integrated production ecosystem—from raw materials to finished reagents, all under complete in-house control.
Figure 1. Screening of novel polymer-modified transfection molecules.
Application Highlights
✅ 2× Higher Full Capsid Ratio
Compared to competitor P, UltraAAV achieves significantly higher full capsid ratios across different DNA/reagent input ratios during AAV9 packaging.
Figure 2. AAV9 packaging results at 1:0.5 and 1:1 DNA/reagent ratios. UltraAAV outperforms in both titer and capsid quality.
✅ Same Yield, Half the Reagent
Achieve comparable viral output with 50% less reagent compared to leading alternatives.
Figure 3. Head-to-head comparison with Company P transfection reagent.
Built for Regulatory Compliance
- ISO13485 Certified Production Facility (Wuhan, China)
Nearly 10,000 m² dedicated to manufacturing.
Modular design enables rapid scale-up and customization.
Supports global clinical and commercial supply, including U.S. and China regulatory audits.
- Stringent Quality Control
Tiered QC system: raw materials – process – final product.
Process analytical technology ensures batch consistency in PEI molecular weight, charge density, and other critical quality attributes.
- Fully Localized Supply Chain
Domestic sourcing of key materials, including high-purity PEI and functional modifiers.
Nationwide logistics network ensures 24-hour response and uninterrupted supply.
Product Information
|
Product Name |
Specifications |
Catalog Number |
|
1 mL / 10 mL / 100 mL |
40823ES03 / 10 / 60 |
|
|
10 mL / 100 mL / 1 L |
40824ES10 / 60 / 80 |