Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products
2004/06/01 by Anthony R. Mire‐Sluis, Anthony R Mire-Sluis, Yu Chen Barrett +17 · 31 citations
Medicine · Immunology and Microbiology · Biochemistry, Genetics and Molecular Biology · #Monoclonal and Polyclonal Antibodies Research #Biosimilars and Bioanalytical Methods #Biotin and Related Studies
paper · doi:10.1016/j.jim.2004.06.002
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