Introduction

Quality control is the cornerstone of biopharmaceutical manufacturing, ensuring the safety, efficacy, and consistency of biologics. As the global biopharmaceutical market continues to grow, projected to reach over $600 billion by 2030, the demand for precise and reliable quality control solutions has never been higher. Hzymes, a leading player in the field of biotechnology, offers advanced Custom Quality Control Kit Development services, tailored to the diverse needs of biopharmaceutical developers. Our expertise spans Host Cell Protein (HCP) detection, Host Cell DNA (HCD) residue detection, and ELISA kit customization.

Understanding Quality Control in Biopharmaceuticals 

Biopharmaceutical products, including recombinant proteins, monoclonal antibodies, and vaccines, require stringent quality control to ensure safety and efficacy. With the increasing complexity of biopharmaceutical production, maintaining consistent quality is a challenge for manufacturers worldwide. Recent industry reports indicate that the quality control market for biopharmaceuticals is expanding rapidly, driven by the demand for safer and more effective therapeutics. One of the critical aspects of quality control is detecting and quantifying residual host cell proteins (HCP), host cell nucleic acids (HCD), and other biomolecules.

Customized Host Cell Protein (HCP) Residual Detection Kit

Service Introduction 

The ELISA method can detect the total content of residual host protein in the test sample, but the detection efficiency of this method is affected by the coverage rate of the residual HCP by the antibody used, and by the difference between the standard and the test sample. Therefore, according to the product production process, the host protein standard and specific antiserum are prepared according to the process, and the establishment of the corresponding detection method can more truly reflect the residual host protein of the test sample.

Hzymes has a professional product R&D team and technical service team. With the company's rich protein and antibody product pipeline, it has rich experience in the research and development of HCP-specific antibodies. We can design scientific experimental schemes according to different needs, develop efficient detection methods, and conduct comprehensive and accurate methodological verification to provide customized development services for host HCP for biopharmaceutical R&D customers.

Market Insight: 

The global HCP detection market is experiencing rapid growth, driven by the increasing adoption of biologics and biosimilars. Regulatory bodies, including the FDA and EMA, require strict HCP monitoring, making customized HCP detection solutions critical for manufacturers.

Service Scope

• HCP detection kit coverage verification

• Development of customized HCP kits for CHO, E. coli, Yeast and other biopharmaceutical expression hosts

Service Highlights

• With rich experience in HCP kit testing and a deep understanding of the process route, we can help customers design reasonable antigen preparation strategies.

• GMP-compliant analytical service laboratories can directly perform method validation and transfer to customer factories.

• With independent intellectual property rights and polyclonal antibody foundation, high-abundance antigens are removed, and the customer's first immunization is the second immunization, which can reduce costs and increase efficiency.

• There are successful cases of kit development, and cooperation accelerates development.

• Perfect production system, one-stop delivery.

Case sharing

Antibody customization example

Project process

Customized Host Cell Nucleic Acid (HCD) Residue Detection Kit

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.

Market Insight

As gene therapies, mRNA vaccines, and recombinant protein drugs become mainstream, the demand for accurate HCD detection is rising. The global HCD detection market is forecasted to grow significantly, with Asia-Pacific and North America leading the demand.

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

Customized ELISA Kit Development

Service Introduction 

ELISA (Enzyme-Linked Immunosorbent Assay) is a detection method based on antigen-antibody interactions in vitro, combining the specificity of antigen-antibody reactions with the high catalytic efficiency of enzymes. It achieves sensitivity at the pg/mL level and is one of the most commercially mature immunoassay technologies, widely applied in medical research, clinical diagnostics, and biopharmaceuticals. ELISA methods can be categorized into two types based on application:

Quantification of biomolecules: Monitoring antibody expression (stable/transient transfection, fermentation processes), cytokine levels, pharmacokinetics of antibody drugs, biomarker quantification, and immunogenicity testing.

Affinity assessment or screening: Hybridoma titer determination, phage display library screening, and evaluation of antibody affinity for target proteins or cell surface receptors.

Hzymes boasts a professional R&D and technical service team, having independently developed multiple ELISA kits. We provide tailored experimental designs, efficient detection method development, comprehensive validation, and customized ELISA testing services or kit development for biopharmaceutical clients.

Market Insight

The global ELISA kits market is expected to grow steadily, driven by rising research in infectious diseases, chronic disease diagnostics, and therapeutic drug monitoring.

Service Scope

• Direct ELISA:

Advantages: Simple, ideal for antibody quantification.

Limitations: Requires conjugated detection antibodies, high background, not suitable for multiplexing.

• Indirect ELISA:

Advantages: Signal amplification via secondary antibodies, higher sensitivity than direct ELISA.

Limitations: More steps, potential for nonspecific binding.

• Sandwich ELISA:

Advantages: High specificity using paired antibodies.

Limitations: Time-consuming and costly antibody pair development.

• Competitive ELISA:

Applications: Quantification of low-abundance analytes, immune response evaluation.
We offer services and kit development for direct, indirect, sandwich, and competitive ELISA, including inhibitor screening, antigen-antibody binding assays, bioactivity analysis, pharmacokinetics, and immunogenicity testing.

Service Advantages

• In-house production of critical reagents:

Self-developed antigens, antibodies, and standards.

• Expert antibody labeling:

Extensive experience in HRP and biotin conjugation.

• Superior performance:

High sensitivity, stability, and accuracy.

• Scalable production:

Controlled batch-to-batch consistency for large-scale manufacturing.

• Rapid delivery:

Customized kits delivered within 2 weeks after reagent preparation.

• Technical expertise:

Capabilities in multiplex ELISA and small-molecule (e.g., nucleic acid) detection.

Case sharing

Universal nuclease detection kit

1.0 HBP000111

Technical principle: ELISA double antibody sandwich method;
Detection range: 0.2~20ng/mL;
Detection limit: ≤0.06ng/mL;
Minimum limit of quantification: 0.2ng/mL;
Precision: Intra-batch CV≤10%, inter-batch CV ≤15%;
Accuracy: Recovery rate range 80%~120%;
Specificity: No cross-reaction with irrelevant proteins such as trypsin, RNase A, DNase I;
Adaptability: It can identify universal nucleases of multiple brands, but the standard product used with this reagent is the universal nuclease of Hzymes, so it is recommended to use the corresponding product to establish a standard curve when detecting other brands of universal nucleases to ensure the accuracy of the measurement results;
Operation process: 6 steps, incubation time 2h, wash 10 times;

2.0 HBP000116

Technical principle: ELISA double antibody sandwich method;
Detection range: 0.02~2ng/mL;
Detection limit: ≤0.01ng/mL;
Lowest limit of quantification: 0.02ng/mL;
Precision: Intra-batch CV≤10%, inter-batch CV ≤15%;
Accuracy: Recovery rate range 80%~120%;
Specificity: No cross-reaction with irrelevant proteins such as trypsin, RNase A, DNase I;
Adaptability: It can identify multiple brands of universal nucleases, but the standard product of this reagent is the universal nuclease of Hzymes, so it is recommended to use the corresponding product to establish a standard curve when detecting other brands of universal nucleases to ensure the accuracy of the measurement results;
Operation process: 8 steps, incubation time 2h30min, wash 15 times;

Antigen and antibody are both homemade.

T7 RNAP Residue Detection Kit (ELISA Method)

48T/96T HBP006004-05

Technical principle: ELISA double antibody sandwich method, one-step operation;
Detection range: 0.25~16ng/mL, R2≥0.99;
Detection limit: <0.1ng/mL;
Minimum limit of quantification: 0.25ng/mL;
Precision: Intra-batch CV <10%, inter-batch CV <15%;
Accuracy: Recovery rate range 80%~120%;
Specificity: Specific recognition of T7 RNA polymerase, other IVT tool enzymes have no interference with the measured value;
Applicability: Suitable for most T7 RNA polymerases on the market;
Operation process: One sample addition, one plate wash, 3 washes, incubation time 75min;

96T HBP008002

Technical principle: ELISA double antibody sandwich method;
Detection range: 0.25~16ng/mL, R2≥0.99;
Detection limit: <0.05ng/mL;
Minimum limit of quantification: 0.25ng/mL;
Precision: intra-batch CV <10%, inter-batch CV <15%;
Accuracy: recovery range 80%~120%;
Specificity: specific recognition of proteinase K;
Operation process: 8 steps, incubation time 3h, washing 12 times;
Customized development: product development and delivery completed in two weeks

Project process

Why Choose Hzymes for Custom Quality Control Kits?

• Proven technical expertise with a strong track record.
• Comprehensive, end-to-end solutions for kit development.
• Dedicated project management for real-time support.
• Fast turnaround with guaranteed results.
• Competitive pricing and global service network.

Conclusion

In the rapidly evolving field of biopharmaceuticals, quality control is non-negotiable. With a strong foundation in biotechnology, Hzymes offers customized, high-performance quality control kits for HCP, HCD, and ELISA applications, ensuring your products meet the highest standards. Leverage our industry expertise and reliable solutions to streamline your quality control processes. Contact us today to learn how we can support your biopharmaceutical R&D and production.