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New Drug Discovery Tools

Help improve the efficiency of new drug development


January 03, 2026


To meet the bioactivity analysis needs in small molecule drug, antibody drug, 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, precisely matching different experimental scenarios and comprehensively improving R&D efficiency.


  • 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 the continuous innovation and development in the biopharmaceutical field, biopharmaceutical products such as antibody drugs, recombinant protein drugs, and vaccines are receiving increasing attention and importance. Chinese hamster ovary (CHO) cells have many advantages, such as suitability for large-scale industrial culture, mature and stable expression systems, resistance to human virus infection, and the ability to express human glycosylation modifications, making them the most widely used engineered cells in biopharmaceutical production.


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 remain in the product. These residual HCPs, once introduced into the human immune system, may pose potential safety risks. From an immunogenicity perspective, they may induce immune responses; furthermore, they may adversely affect the product's stability and efficacy. Therefore, the issue of residual HCPs in protein drugs has become a key factor in whether biologics can obtain regulatory approval.


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 host cell protein (HCP) clearance efficiency due to its high sensitivity, high 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.


Luciferase Cell-based Assays


These reagents utilize the enzymatic oxidation and luminescence reaction of luciferase with its substrate to precisely quantify bioluminescent signals, enabling the detection of luciferase reporter gene expression levels or endogenous ATP. They 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: This method is free from endogenous interference, has low background values, high sensitivity, and a wide detection window. Furthermore, it allows for detection without cell lysis, significantly improving high-throughput screening efficiency and making it suitable for various experimental scenarios.

Cell viability assays: Cytotoxicity assays are a crucial step in antibody-drug conjugate (ADC) drug development, used to 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, and 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.


CellCounting-Lite 2.0 (CCL2) is a cell viability assay that detects the amount of ATP released by living cells through a luminescent signal based on a luciferase system.

 

CellCounting-Lite 3D (CCL3D) is a cell viability assay that detects the amount of ATP released by micro-tissue cell clump, sphenoid or organoids under 3D cell culture conditions.

 

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


 

  • DD1205 - Duo Luciferase Assay System: A glow dual luciferase reporter gene detection kit, featured by high sensitivity, stability and homogeneity, is easy to operate, and has a fluorescence half-life of 2 h, which is very suitable for high-throughput operation.


In vivo Imaging Potassium Salts: Visually tracks disease progression by detecting in vivo luciferase expression levels.

 

 

Add&Read® TR-FRET Solution

 

Technological breakthrough: A rapid homogeneous detection method based on the TR-FRET principle (Figure 1), significantly simplifying the process compared to traditional ELISA—eliminating cumbersome steps such as coating, washing, and color development. Only two steps are required: sample addition and detection, saving over 80% of labor and time costs. It is perfectly compatible with automated equipment and high-throughput experimental scenarios, significantly improving detection efficiency.

 



  

Human/Mouse IgG Quantitative Detection: 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: Accurately measures cytokine levels in cell supernatants, aiding cell therapy research. This method 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: Quantitatively detects intracellular second messenger cAMP levels, accelerating high-throughput screening of GPCR-targeted drugs.

 


 

 

 

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.


 
 
 

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