Challenges in the Molecular Diagnostics Industry
As the demand for sensitivity in molecular diagnostic kits continues to grow, mainstream detection methods like PCR, mNGS (metagenomic next-generation sequencing), and tNGS (targeted next-generation sequencing) face increasingly stringent requirements. A key challenge arises when detecting low-abundance target molecules: trace genomic DNA residues in commercially available conventional DNA polymerases can lead to contamination. Even minute amounts of contaminating DNA can cause non-specific amplification, reducing amplification efficiency and compromising the accuracy of positive predictive values—a significant hurdle for developers.
Moreover, when detection targets involve residual host DNA or exogenous nucleic acids within the amplification system, peaks often appear in no-template controls (NTC) and negative samples, complicating result interpretation. For instance, as shown in Figure 1, the closer the amplification cycle threshold (Ct) value of Sample B is to the NTC, the more ambiguous the outcome becomes. Reliable results depend on clear separation between the NTC and sample amplification curves. When target concentrations in samples are low, shifting the NTC curve to the right (i.e., to a higher Ct value) enhances detection reliability. Using ultra-pure molecular enzyme raw materials achieves this shift, delivering:
- Improved Detection Reliability: Better separation between sample and negative control for the same sample.
- Enhanced Sensitivity: A lower limit of detection with maintained separation from NTC, enabling detection of scarce targets.
Figure 1: Sample A has a higher target concentration than Sample B, but most real-world samples resemble Sample B with lower concentrations. A delayed NTC Ct value increases both detection sensitivity and reliability.
The Logic Behind Low-Residue and Fully Premixed System Development
To tackle interference from background bacteria and host nucleic acid residues in pathogen detection, YeasenBio has developed ultra-low-residue purification technology. This innovation provides cleaner, high-performance molecular enzyme raw materials for clinical diagnostic kit developers and research institutions. Our solution includes the establishment of UCF.ME™, an ultra-clean molecular enzyme production base adhering to Good Manufacturing Practice (GMP) standards, and strict compliance with the ISO 13485 quality management system. This ensures meticulous control over personnel, equipment, reagents, consumables, processes, environment, and standards.
By integrating advanced technical approaches, a pristine production environment, and rigorous quality controls, we effectively manage both exogenous and endogenous impurities. The result is ultra-clean molecular enzymes with cleanliness levels several orders of magnitude higher than conventional commercial products—ideal for applications demanding exceptional sensitivity and reliability.
Figure 2: YeasenBio ultra-low-residue molecular enzyme quality monitoring flowchart.
Ultra-Low Residue Removal Technology
Traditional molecular enzyme production involves complex, multi-step purification processes that often yield low outputs. Achieving a balance between purity and yield in low-residue, high-purity enzyme production is notoriously difficult, leading to inconsistent batches. YeasenBio’s proprietary ultra-low residue removal technology overcomes these challenges by targeting specific residues with precision. This streamlined purification process boosts efficiency, stability, and yield while minimizing batch-to-batch variability.
Figure 3: Schematic diagram of YeasenBio’s ultra-low residue removal technology.
UCF.ME™: Ultra-Clean Molecular Enzyme Production Base with GMP Standards
UCF.ME™ (Ultra Clean Factory for Molecular Enzymes) is a state-of-the-art facility engineered to achieve exceptional enzyme purity through cutting-edge purification technologies:
- Closed System: A fully enclosed production system with sterile tanks and pipelines, equipped with an automated CIP/SIP (Clean-in-Place/Sterilize-in-Place) system, drastically reduces DNA contamination risks.
- Environmental Control: Production occurs in cleanrooms meeting Grade D, Grade C, and local Grade A standards, safeguarding against DNA contaminants and ensuring enzyme purity.
- Hardware Assurance: Imported, customized equipment enables real-time monitoring and adjustment of critical parameters, ensuring precision and full data traceability.
- Water Quality Control: Adheres to the 2020 China Pharmacopoeia standards, guaranteeing sterile production water.
- Scalability: Ton-level mass production ensures uniformity, stability, and timely supply while optimizing costs.
ISO 13485 Quality Management System
As the first company in China to achieve ISO 13485:2016 certification for molecular enzyme products, YeasenBio upholds stringent quality standards across raw material procurement, production, quality control, warehousing, and logistics. Dynamic monitoring spans personnel, equipment, materials, processes, environment, and measurements, all governed by standardized SOPs. This ensures traceability, compliance, and consistent delivery of high-quality products that meet regulatory and customer expectations.
Figure 4: YeasenBio’s ISO 13485-certified ultra-clean molecular enzyme production base.
Key Innovations and Platform Outputs
Comparative studies show that low-residue enzymes outperform conventional enzyme materials by delivering earlier Ct values and boosting system performance. Additionally, these enzymes significantly increase the success rate of developing fully premixed PCR systems.
YeasenBio offers a comprehensive portfolio of low-residue, ultra-clean molecular enzyme raw materials, including Taq DNA polymerase, reverse transcriptase, UDG enzyme, RNase inhibitor, and compatible buffers. These products empower academic and industrial users to create cleaner, more efficient diagnostic kits, supporting:
- Low-Residue Systems: Ideal for detecting sequences similar to genomic DNA from common hosts (e.g., E. coli) or environmental bacteria, with DNA contamination as low as <0.02 copies/100 U.
- High-Sensitivity Systems: Perfect for developing or upgrading assays to detect low-concentration targets, improving primer-template binding and NTC separation.
- Fully Premixed Systems: Validated for stability with over 20 primer-probe sets at 37°C for 7 days, ensuring compatibility and flexibility in qPCR/RT-qPCR formulations.
Performance Highlights
1. Ultra-Low Contamination: E. coli genomic DNA residue <0.02 copies/100 U—the industry’s lowest level.
Figure 5: Residual E. coli DNA detection in three batches of YeasenBio UCF.ME™ Taq enzyme (Cat#14319ES, 14321ES).
2. qPCR Premix Stability: Accelerated stability test at 37°C for 7 days demonstrates superior performance.
Figure 6: Low-residue Taq and UDG enzymes, premixed with HPV and internal standard primers, show no change in amplification curve shape, fluorescence, or Ct value compared to -20°C controls.
3. RT-qPCR Premix Stability: Accelerated test at 37°C for 5 days confirms high stability.
Figure 7: Low-residue RT-qPCR components maintain consistent amplification, fluorescence, Ct values, and detection rates versus -20°C controls.
Why Choose YeasenBio?
- Ultra-Clean Enzymes: Optimized for high-sensitivity IVD kits.
- GMP-Grade Production: Backed by ISO 13485 certification.
- Scalable Solutions: Reliable supply with expert technical support.
For collaboration or inquiries, contact Yeasen Biotech today!
Recommended Products
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Category |
Product Name |
Product NO. |
|
Taq DNA Polymerase |
Hieff UNICON UCF.ME™ Advanced Hotstart Taq DNA Polymerase (20 U/μL) |
|
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Reverse Transcriptase |
Hifair™ V Reverse Transcriptase |
|
|
UDG |
UCF.ME™ Uracil DNA Glycosylase (UDG/UNG), heat-labile, low DNA, 1 U/μL |
|
|
RNase Inhibitor |
UCF.ME™ Murine RNase Inhibitor (40 U/µL) |
|
|
Buffer |
5×E-Taq DNA Polymerase PCR Buffer |
16715ES |
|
|
5×Taq DNA Polymerase PCR Buffer |
16716ES |
|
|
2×TaqMan Multiplex RT-qPCR Buffer |
16718ES |