Custom Services

Moving beyond the traditional ODM/OEM business model, cnpair, as a core raw material enterprise,oving beyond the traditional ODM/OEM business model, cnpair, as a core raw material enterprise, possesses comprehensive capabilities to develop IVD products from the ground up.

1 Basic Research:

We provide foundational experimental support, including microbial culture and immunized animal rearing, to lay the foundation for subsequent R&D.

2 Raw Material Development:

We design immune protocols for specific targets, complete animal immunization, cell fusion and hybridoma screening, and obtain high-affinity monoclonal antibodies; At the same time, we use prokaryotic and eukaryotic systems to achieve microbial culture and recombinant expression of recombinant antigens/ enzymes.

3 Material Processing:

Our services include lyophilization, special treatments, and professional conjugation services such as magnetic beads/ AP/ AE/ HRP/ Biotin conjugates.

4 Registration Regulation:

Relying on a professional technical team and a full-chain support system, we provide customers with precise and efficient registration regulation services. According to the product type and characteristics, we assist customers in tailoring registration strategies and follow up on the execution of key experiments such as performance testing throughout the process.Through professional technical document services, we assist in organizing and standardizing the registration technical materials to ensure their logical coherence and complete data. In addition, our team is familiar with the technical characteristics and regulatory project management of different products, and can provide full-process support for customers.

5 Process Optimization:

Cnpair provides technical services for IVD reagent development to clients. Leveraging our expertise, we assist clients in completing tasks such as coating, labeling, buffer optimization, and reaction reagent optimization in the development of immunoassay and molecular diagnostic reagents, thereby accelerating the product development timeline. Additionally, Cnpair possesses IVD manufacturing facilities that comply with the standards of the National Medical Products Administration (NMPA) of China and can undertake contract manufacturing of IVD reagents in accordance with the requirements of the Marketing Authorization Holder (MAH) regulations. Cnpair also has a well-equipped Biosafety Level 2 (BSL-2) laboratory, which has been audited and approved by Health Commission of Zhejiang Province, and Cnpair can help clients conduct a series of bacterial cultures and testing work, serving as an experimental component in research and development or product registration.

6 CDMO：

Cnpair provides customized products for CLIA, ELISA, and LF platforms according to customer requirements.