Immunology (China)

Overview

The highly experienced professionals in the Immunology and Assay Support Department at our Beijing facility are fully equipped to provide our clients a wide range of immunology services. With their in-depth GLP/GMP compliance knowledge and the advanced instrumentation at their disposal, our staff can deliver the immunologic services needed to support biologic product development.

Assay Development and Validation

We develop and validate assays according to US FDA/ICH guidelines with the following assay formats:

• Ligand binding (ELISA, EIA, RIA)

• Cell-based

• FACS-based

• Receptor-binding

• Biochemical

• Coagulation

Bioanalytical Sample Testing

Our testing service is GLP-compliant and the laboratory operates per the "Good Bioanalytical Practices" principle, ensuring timely delivery of quality results to our clients.

• Pharmacokinetic testing for biologics

• Toxicokinetic testing for biologics

• Immunogenicity testing

• Biomarker testing

Immunotoxicity Testing

We can provide standard and supplemental immunotoxicity tests, in accordance with ICH guidelines, to determine adverse effects of human pharmaceuticals on the immune system.

• Hematological analysis

• Immune system organ weight and/or histology

• Quantification of serum globulins

• Immunophenotyping of leukocytes by FACS

• Determination of NK cell activity

• Evaluation of T-cell dependent antibody response by KLH immunization

Product Development and Analytical Testing Support

The technical professionals at our Beijing facility have a thorough understanding of the biologic product development process, knowledge that enables them to perform analytical assays that will facilitate your product development effort and minimize CMC issues.

 

Tests provided include:

• Antigen binding activity

• Host cell protein impurity

• Insulin impurity

• Potency

• Protein A impurityn