Typically, PK assays focus on measuring conjugated antibodies, total antibodies, and the released payload. Sino Biological has developed anti-payload antibodies that exhibit high purity ...
His research is focused on developing and utilization of PK assays as well as the assays designed to evaluate development of immune responses to biotherapeutic compounds.
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FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugatesand limitations of each assay, differences in the matrix (e.g., plasma, tissue, or urine), the sensitivity of detection required as well as the objectives for the analysis (quantitative PK ...
A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration that immunogenicity assays may be necessary to measure immune responses to ...
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