Service introduction

Recombinant protein drugs, antibody drugs, vaccines and other products in biological products are expressed and produced by continuously passaged animal cell lines. Strict purification processes can remove some residual impurities such as host cell DNA (HCD), but HCD residues may still remain in the product. These residual exogenous host cell DNA will cause potential safety issues (such as potential tumorigenicity, infectiousness, and even increased immunogenicity or mutation). Therefore, the HCD detection project is an important quality control key link in the production process of biological products. The 2020 edition of the "Chinese Pharmacopoeia", General Chapter 3407 includes 3 methods for the determination of exogenous DNA residues: DNA probe hybridization method, fluorescent staining method, and quantitative PCR method. The quantitative PCR method is the exogenous DNA residue determination method confirmed by the Chinese Pharmacopoeia, and it is also the only recommended standard method for the detection of host residual DNA in biological products in the new version of USP, and the qPCR method has high sensitivity, sequence specificity and accuracy.
Hzymes has a professional product development team and technical service team, and has accumulated a lot of analytical method development experience and experimental data on various bioanalytical detection platforms. We can design scientific experimental plans according to different needs, develop efficient detection methods, and conduct comprehensive and accurate methodological verification to provide HCD detection services and HCD kit development services for biopharmaceutical R&D customers.

Service scope

Hzymes has different host residual DNA detection products, covering CHO, E.coli, Vero, HEK293, Pichia pastoris, mycoplasma and other cell types. The primer probe sequence of the kit is from the pharmacopoeia, and there is no need to do a full set of verification experiments, only method confirmation is required. According to the quantitative PCR method development, the LOD can reach 0.003 pg/μL, with no cross reaction with other DNA, reducing the false positive of the detection reaction. Strict production management system, batch difference can be controlled CV <10%. Provide a complete set of solutions for manual extraction and automated instrument extraction, quickly complete the detection within 2h, and ensure the accuracy of quantitative detection.

Service highlights

• Quick response, one-to-one service by the project team, real-time follow-up of experimental progress.
• Professional R&D technical team, rich project experience
• A lot of internal R&D data, shortening the experimental cycle
• Application-guaranteed service, delivery sensitivity meets regulatory requirements.

Case sharing

The standard in the CHO HCD kit is calibrated with the national CHO DNA standard. The same kit is used to detect standards from different manufacturers. The measured value deviation of the Hzymes standard is less than 5%.

Project Process

Service Cycle

Service Process

• Customer Consultation
• Technical Evaluation
• Issue Contract
• Start Service
• Issue Report
• Customer Confirmation, File Archiving