Press Releases

Profacgen, a state-of-the-art protein service provider offering custom protein services in the biological sciences, now provides immunogenicity testing services to help its customers to accelerate their drug discovery and development programs.

Immunogenicity testing is a key part of biopharmaceutical development. More stringent regulations regarding immunogenicity assay performance require the development of assays that exhibit excellent sensitivity, precision, free drug tolerance, and minimal matrix effect. Immunogenicity assays can be used to detect and confirm anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) that support nonclinical and clinical studies.

Immunogenicity determination can be challenging due to interference originating from the sample matrix, drug interference, or target interference. In order to design a reliable immunogenicity assay, it is very important to start with a suitable assay platform and high-quality reagents. There are two main strategies based on biosimilarity immunogenicity procedures using a single assay or two separate assays.

Based on its GLP-compliant service laboratories, Profacgen participated in an international workshop and developed an R & D program to lead the latest developments in the field. Now Profacgen supplies the following immunogenicity testing services:

Ligand Binding Assay

Cell Based Assays

Total Antibody Assay

Neutralizing Antibody Assay

Particle Size Characterization

Critical Reagent Characterization

Protein Aggregation Analysis

“Our immunogenicity team has developed and validated in vivo and in vitro assays for many of our customers to screen and quantify immunogenicity caused by anti-drug antibodies and impurities. Our team of scientists will work closely with you to develop a custom panel of immunogenicity assays.” Commented Crystal, the chief marketing staff at Profacgen.

For drug development, Profacgen also provides Biopharmaceutical Process and Product Related Impurities Analysis, Biosimilar Testing Services, Induced Protein Degradation, PROTAC Discovery and Development, and Stability Analysis Services. To know more details about those services, please visit https://www.profacgen.com/drug-development.htm.