Chapter 7: Case studies: challenges of developing and validating PK and immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars

apDoi: 10.4155/FSEB2013.14.134 Authors Xiao-Yan Cai* Executive Director Division of Global Bioanalytical Services for Large Molecules WuXi AppTec 107 Morgan Lane, Plainsboro NJ 08536, USA Tel.: +1 609 418 0117 e-mail: [email protected] Dominique Gouty Vice President Business Operations BioAgilytix Labs 2300 Englert Drive, Durham, NC 27713, USA Tel.: + 1 919 287 1526 e-mail: [email protected] *Corresponding Author About the Authors Xiao-Yan Cai Xiao-Yan Cai, Ph.D, is Executive Director at WuXi AppTec Global Bioanalytical Services (BAS, Shanghai, China) for large molecules. Prior to her current role, she was Director at Merck’s Biologics Bioanalytical Development division. She has over 20 years of experience...

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