top of page

New Drug Discovery Tools

  • Jan 5
  • 5 min read

Updated: Apr 4

Help Improve the Efficiency of New Drug Development


Technical Note | TACT Genomics, January 03, 2026


To meet the bioactivity analysis needs in small molecule drugs, antibody drugs, cell and gene therapy, and vaccine development, our newly developed drug development reagent portfolio currently comprises three main categories: luciferase assays, wash-free ELISA kits, and residue detection kits. Among these, the wash-free ELISA series offers flexible and customized method development services. This flexibility matches different experimental scenarios and comprehensively improves R&D efficiency.


Overview of Our Reagent Portfolio


  • CHO HCP ELISA Kit (Residue detection reagent)

  • Luciferase Cell-based Assay (Reagents for detecting luciferase reporter gene or ATP)

  • Add&Read TR-FRET Solution (Add&Read® based wash-free ELISA)


With continuous innovation in the biopharmaceutical field, products such as antibody drugs, recombinant protein drugs, and vaccines are gaining importance. Chinese hamster ovary (CHO) cells have many advantages. They are suitable for large-scale industrial culture, have mature and stable expression systems, resist human virus infection, and can express human glycosylation modifications. This makes them the most widely used engineered cells in biopharmaceutical production.


Understanding Host Cell Proteins (HCPs)


When expressing target proteins using CHO cell lines, host cell proteins (HCPs) are generated as byproducts. Although purification processes can remove over 99% of HCPs, some may remain in the final product. These residual HCPs can pose potential safety risks when introduced into the human immune system. From an immunogenicity perspective, they may induce immune responses and adversely affect the product's stability and efficacy. Therefore, the issue of residual HCPs in protein drugs is crucial for obtaining regulatory approval.


Regulatory Standards for HCP Residues


Each country has established strict regulations on HCP residues:


  1. The United States Pharmacopeia (USP) stipulates in its <1132> chapter that the limit for HCP content is less than 0.01% (100 ppm) [1].

  2. ICH Q6B states that the HCP residue is generally required to be less than 100 ppm [2].

  3. The Chinese Pharmacopoeia (2020 edition) stipulates that the HCP residue in CHO cells must be less than 0.05% (500 ppm) [3].

  4. The European Pharmacopoeia (EP 2.6.34) stipulates that the HCP content should be less than 0.1% (1000 ppm) [4].


Host Cell Residue Detection


In biopharmaceutical quality control, ELISA is widely considered the preferred method for assessing HCP clearance efficiency. This is due to its high sensitivity, specificity, and support for high-throughput detection. Safety is central to the entire R&D and manufacturing process in biopharmaceuticals.


Our Vazyme brand CHO HCP ELISA kit is a one-step double-antibody sandwich ELISA kit for HCP detection. It requires only one incubation step to quickly and accurately quantify CHO HCP residues in samples while strictly adhering to biopharmaceutical quality control standards. Our host cell residue detection product provides reliable assurance for biopharmaceutical safety.


  • DD8102 - CHO HCP ELISA Kit: This kit is designed to detect residual host cell proteins in biological products (such as antibodies, recombinant proteins, vaccines, etc.) expressed in CHO cell lines.


The Role of Luciferase Cell-based Assays


Luciferase cell-based assays utilize the enzymatic oxidation and luminescence reaction of luciferase with its substrate. This allows for precise quantification of bioluminescent signals, enabling the detection of luciferase reporter gene expression levels or endogenous ATP. These assays can be used for in vitro or in vivo detection, such as cell viability assays, antibody-dependent cell-mediated cytotoxicity (ADCC)/ADCP effect detection, and in vivo imaging.


Key Advantages of Luciferase Assays


This method is free from endogenous interference and has low background values. It also boasts high sensitivity and a wide detection window. Furthermore, it allows for detection without cell lysis, significantly improving high-throughput screening efficiency. This makes it suitable for various experimental scenarios.


Cell Viability Assays


Cytotoxicity assays are crucial in antibody-drug conjugate (ADC) drug development. They help screen suitable ADC candidates and lay the foundation for subsequent in vivo activity/potency evaluation. Simple, rapid, and highly sensitive ATP assays are increasingly favored by pharmaceutical companies for potency analysis in both ADC raw material (DS) and finished drug product (DP) development stages. These assays are gradually becoming the "gold standard" for cell viability testing. Vazyme CellCounting-Lite (CCL) products, which detect ATP levels to reflect cell metabolism, are commonly used for high-throughput, rapid assessment of the proliferation-inhibiting activity or cytotoxicity of antibody-drug conjugates.


Reporter Gene Assays


Reporter genes are widely used to detect cell signal transduction and gene expression. They are suitable for revealing the regulatory mechanisms of target gene expression and drug bioactivity.


  • DD1201 - Bio-Lite Luciferase Assay System: Bio-Lite Luciferase Assay System detects the firefly luciferase reporter gene with ultrahigh sensitivity, stability, and homogeneity.


  • DD1205 - Duo Luciferase Assay System: A glow dual luciferase reporter gene detection kit, featuring high sensitivity, stability, and homogeneity. It is easy to operate and has a fluorescence half-life of 2 hours, making it very suitable for high-throughput operations.


In Vivo Imaging Potassium Salts


This method visually tracks disease progression by detecting in vivo luciferase expression levels.


Add&Read® TR-FRET Solution


Technological Breakthrough


The Add&Read® TR-FRET Solution represents a rapid homogeneous detection method based on the TR-FRET principle. This significantly simplifies the process compared to traditional ELISA by eliminating cumbersome steps such as coating, washing, and color development. Only two steps are required: sample addition and detection. This saves over 80% of labor and time costs. It is perfectly compatible with automated equipment and high-throughput experimental scenarios, significantly improving detection efficiency.


Add&Read TR-FRET Solution

Human/Mouse IgG Quantitative Detection


This solution efficiently screens cell lines expressing high levels of antibodies, accelerating upstream process development. The Add & Read method based on TR-FRET technology is also known as "wash-free ELISA." Compared with traditional ELISA, it only requires two steps, saving more than 80% of time and labor.


Cytokine Quantitative Detection


This method accurately measures cytokine levels in cell supernatants, aiding cell therapy research. It is based on TR-FRET technology, also known as "wash-free ELISA." Compared with traditional ELISA, it only requires two steps, saving more than 80% of time and labor.


cAMP Quantitative Detection


This method quantitatively detects intracellular second messenger cAMP levels, accelerating high-throughput screening of GPCR-targeted drugs.


Conclusion


In conclusion, our innovative reagent portfolio is designed to enhance the efficiency of new drug development. By focusing on the needs of biopharmaceutical researchers, we aim to empower them to advance their discoveries and improve molecular diagnostics worldwide. The combination of our wash-free ELISA kits, luciferase assays, and residue detection kits provides a comprehensive solution for the challenges faced in drug development.


References:

[1] (USP) <1132> Residual Host Cell Protein Measurement in Biopharmaceuticals.

[2] ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products.

[3] Chinese Pharmacopoeia, 2020 edition.

[4] EP-2.6.34. HOST-CELL PROTEIN ASSAYS.

 
 
 

Comments

bottom of page