Whether expressed in prokaryotic or eukaryotic systems or used in the production of biopharmaceuticals, residual impurities exist to varying degrees. Therefore, residue detection is essential; otherwise, product quality will be severely affected.
Following the 2025 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 3407, Determination of Residual Exogenous DNA, HyQure Biotech has developed a quantitative qPCR method to detect residual exogenous DNA, supporting impurity control strategies, potency determination, and regulatory submissions.
HyQure Biotech Provides the following residual impurity testing services
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Subdivision |
Product Name |
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Auxiliary reagent kit products |
Host cell residual DNA sample preparation kit (magnetic bead method) |
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Auxiliary reagent kit products |
Host Cell Residual DNA Sample Preparation Kit (Magnetic Bead Method) - Enhanced |
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Host cell residual DNA detection |
HEK293 Residual DNA Detection Kit (PCR-Fluorescent Probe Method) |
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Host cell residual DNA detection |
E. coli Residual DNA Detection Kit (PCR-Fluorescent Probe Method) |
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Host cell residual DNA detection |
CHO Residual DNA Detection Kit (PCR-Fluorescent Probe Method) |
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Host cell residual DNA detection |
Pichia pastoris residual DNA detection kit (PCR-fluorescent probe method) |
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Host cell residual DNA detection |
Vero Residual DNA Detection Kit (PCR-Fluorescent Probe Method) |
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Host cell residual DNA detection |
Human Residual DNA Detection Kit (PCR-Fluorescent Probe Method) |
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Host cell residual DNA detection |
CHO Residual DNA Fragment Analysis and Detection Kit (PCR-Fluorescent Probe Method) |