Hyasen Biotech: Authorized Validation! Our HEK293 Detection Kits Earn Recognition from Leading Russian Research Institute, Empowering Biopharma QC Excellence
As an innovator in biopharmaceutical quality control, Hyasen Biotech is proud to announce that our HEK293 HCP ELISA Kit and HEK293 Residual DNA Detection Kit have successfully passed an independent and rigorous validation.
The validation was conducted together with the N.F. Gamaleya National Research Center for Epidemiology and Microbiology, a leading Russian institution affiliated with the Ministry of Health.
The results confirm that both kits deliver high sensitivity, reliability, and consistency, making them suitable for routine quality control in biopharmaceutical manufacturing!
Core Validation Highlights: Delivering Rigorous Performance
ELISA for Residual HCP Detection:
- Calibration curves show R² > 0.98.
- Simple operation and reproducible results.
- Well suited for daily QC workflows.
Real-Time qPCR for Residual DNA Detection:
- Excellent linearity (R² = 0.999).
- Assay efficiency of 97.29%.
- Detects residual DNA levels as low as 0.03 pg/μL.
Reliability and Specificity:
- No cross-contamination detected.
- No non-specific amplification signals.
- Confirmed by blank controls and internal quality checks.
These results ensure data integrity and confidence in QC decision-making.
Hyasen Biotech has extensive experience in developing fast, reliable, and customized quality control solutions for the biopharmaceutical industry.
Our QC product portfolio includes:
- N-Glycan analysis kits.
- Host cell protein and DNA detection kits (CHO, HEK293, coli, etc.).
- Residual Protein A detection kits.
- mRNA synthesis systems (high-yield T7 IVT reagents, T7 RNA polymerase).
- Other residual detection kits (fluorescent DNase/RNase assays).
Quality in biopharmaceutical products starts with accurate detection.
At Hyasen Biotech, we focus on providing accurate, reliable, and efficient QC solutions that help pharmaceutical companies ensure product safety and accelerate development timelines.
Contact us to learn more about our QC solutions or to discuss custom requirements. Let's drive excellence in biopharmaceutical quality control!