Immunogenicity and Immunotoxicity Studies

Core Service Contents

Immunogenicity Testing Services

Immunogenicity is one of the critical safety risks for biologics, peptides and protein drugs. Immunogenicity testing aims to accurately evaluate drug-induced specific immune responses, characterize anti-drug antibody formation and changes in immune indicators, and provide scientific evidence for clinical safety control, dosage adjustment and global drug registration.

•Pre-existing neutralizing antibody detection

•Binding antibody detection

•Neutralizing antibody detection

•Cellular immunity detection

•Anti-drug antibody (ADA) detection

Immunotoxicity Testing Services

•Immune cell phenotyping

•Cytokine and chemokine detection

•Immunoglobulin and immune complex detection

•Detection of specific cytokine secretion by T cells targeting transgenic products

•Complement activation detection

•Anaphylactic reaction evaluation

Professional Testing Platforms

Advanced testing platforms guarantee accurate and reliable immunogenicity and immunotoxicity test data. JOINN has built world-class immune testing systems equipped with internationally advanced instruments and standardized SOP and quality management systems. Supported by experienced technical teams, the platforms support multi-dimensional testing for various drug types and ensure accurate interpretation and scientific analysis of test results.

•LC-MS/MS Platform

•ELISA / Cytometric Bead Array (CBA) Platform

•MSD Platform

•HPLC-UV/RID Platform

•Q-PCR / RT-PCR Platform

Core Technical Advantages

•Leading Compliance: Fully aligned with global regulatory guidelines and GLP standards with traceable data, supporting global new drug registration.

•Advanced Testing Platforms: Equipped with high-end precision instruments to deliver high-accuracy immune testing consistent with international advanced standards.

•Professional Expert Team: Multi-disciplinary senior technical team provides one-stop full-process immune evaluation and professional risk assessment services.

•Customized Services: Tailored immunological evaluation solutions based on drug characteristics and global registration requirements.

•Accurate and Reliable Data: Standardized experimental procedures minimize errors and ensure compliant and credible data recognized by global regulators and clients.

Success Cases

Case 1

Comprehensive immunogenicity evaluation for an innovative biologic

The client entrusted JOINN to conduct full-set immunogenicity tests including pre-existing neutralizing antibody, binding antibody, neutralizing antibody and cellular immune assays to support FDA IND submission. With the advanced MSD platform and professional technical team, we customized study designs in strict accordance with FDA and ICH guidelines, delivered accurate detection and data analysis, supported successful FDA IND approval, and laid a solid foundation for clinical development.

Case 2

Immunotoxicity evaluation for a protein drug

To meet the immunotoxicity risk assessment needs of a protein drug, JOINN performed full-dimensional evaluations including immune cell phenotyping, cytokine profiling, complement activation and anaphylaxis assessment. Combined with flow cytometry and ELISA technologies, we accurately quantified immune indicators, analyzed toxicological mechanisms, provided professional risk optimization suggestions, helped avoid immune-related risks, and accelerated clinical progression.

Case 3

Anti-drug antibody detection for a peptide drug

Joinn conducted ADA detection for a peptide drug to support NMPA and EMA registration. Adopting a combined LC-MS/MS and ELISA strategy, we improved detection sensitivity and specificity under EMA and NMPA guidelines. Standardized testing procedures ensured accurate and compliant data, supporting smooth regulatory review and product launch.