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Technical service

Service Background

Host Cell Proteins (HCP) pose potential risks to drug quality and patient safety, and their residual levels are required to be tested as specified in pharmacopoeias of multiple countries. Commercial universal detection kits can be used in the early stage of process development; however, once a biopharmaceutical enters Phase III clinical trials, a product-specific HCP ELISA kit is required, i.e., an HCP detection kit developed for the specific product (or process).


Junyan Bio boasts a mature and comprehensive technical platform, capable of providing customized development services for HCP detection targeting different host cells. Leveraging an efficient antibody development platform and advanced instrumentation, the company delivers end-to-end services covering HCP antigen characterization, preparation and analysis of high-coverage HCP antibodies, development and validation of analytical methods, and large-scale production of kits. This ensures the development and stable supply of high-quality HCP ELISA detection kits. Our unremitting pursuit of technology and strict quality control are committed to providing you with a reliable and efficient service experience.

Customization Process

  • 01 Pre-project Communication

  • 02 Establishment of HCP Antigens and Standards

  • 03 Preparation and Characterization of HCP Polyclonal Antibodies

  • 04 Development and Validation of ELISA Methods

  • 05 Delivery of Project Outcomes

Service Cycle and Price
Service Cycle：4-8 months
Price：Pricing will be determined after the plan is confirmed.
Service Advantage

  • 01 High-resolution LC-MS is used for comprehensive characterization of antigens to obtain HCP identity information.

  • 02 With rich experience in HCP antibody preparation, multiple strategy combinations are adopted to ensure the acquisition of high-quality antibodies.

  • 03 Advanced AAE-MS antibody coverage detection platform is applied for antibody characterization.

  • 04 Development and transfer to production are carried out in strict compliance with the ISO13485 quality management system, with acceptance of on-site customer audits.

  • 05 A professional technical team provides full-process services, with real-time reporting and communication on project progress.


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Contact Us
Sales： +86 15234188795/18701864343
Tech ：  +86 19503412257
E-mail： sales@junyanbios.cn
Add： Building D, No. 13 Building, Liandong U Valley Taiyuan Science and Technology Innovation Center, No. 100 Tanghuai Road, Xiaodian District, Taiyuan City, Shanxi Province
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