List of White papers

 

Immunogenicity white papers

Gupta S, et.al., Recommendations for the validation of cell-based assays used for the detection of neutralizing antibody immune responses elicited against biological therapeutics. J Pharm Biomed Anal. 2011 Jul 15;55(5):878-88. PMID: 21531522

Gupta S, et.al, Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J Immunol Methods. 2007 Apr 10;321(1-2):1-18. PMID: 17307199

Shankar G, et.al., Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal. 2008 Dec 15;48(5):1267-81. PMID: 18993008

Mire-Sluis AR, et.al., Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004 Jun;289(1-2):1-16. PMID: 15251407

 

European bioanalysis forum (EBF) publications

Link to EBF publications

Link to other publications recomended by EBF

 

Relevant USP chapters for potency assays

USP General Chapters <111> Design and analysis of biological assays

USP General Chapters <1032> Design and Development of Biological Assays

USP General Chapters <1033> Biological Assay Validation

USP General Chapters <1034> Analysis of Biological Assays