Profacgen, an expert in protein-related services, recently updated its Immunogenicity Assay services worldwide, aiming to help researchers smoothen their drug development. Now in vivo and in vitro assays to screen and quantify immunogenicity caused by anti-drug antibodies and impurities are available.
Immunogenicity testing is an indispensable step in the development of antibody drugs and needs to be carried out in both preclinical and clinical stages. Immunogenic drugs may induce harmful immune responses in the body, which can form anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs). The former can cause a strong immune response in patients, and even endanger the lives of patients, while the latter can neutralize the ability, inhibit the biological activity of biological drugs and weaken its efficacy. Therefore, considering that immunogenicity can seriously affect the effectiveness and safety of drugs, FDA and other drug regulatory agencies require that all biopharmaceuticals be tested for immunogenicity.
“Based on our GLP-compliant service laboratories, Profacgen is involved in international workshops and has R&D programs to keep ahead of the latest developments in this area, so that we can best help our customers to accelerate their drug discovery and development programs.” Commented the official speaker from Profacgen.
Now customers can choose from the wide range of immunogenicity testing services offered by Profacgen including: Ligand Binding Assay, Cell Based Assays, Total Antibody Assay, Neutralizing Antibody Assay, Particle Size Characterization, Critical Reagent Characterization, and Protein Aggregation Analysis.
Based on the risk profile of the biotherapeutic protein or antibody and its intended use, the team in Profacgen will work closely with its clients to develop a custom panel of immunogenicity assays. For more information, please visit https://www.profacgen.com/immunogenicity-testing-services.htm.
About Profacgen
Profacgen provides process development and cGMP manufacturing services for biological active ingredients. We have ready access to state-of-the-art biopharmaceutical product development and manufacturing facilities and our staff scientists have demonstrable expertise in all aspects of biopharmaceutical manufacturing, from facility design and operation to the ability to provide best advice relating to product development.