title: Biotherapeutic bioanalysis: a multi-indication case study review.
abstract: A thorough understanding of the structure and biology of a biotherapeutic is crucial to defining a suitable strategy for pharmacokinetic characterization in proof-of-concept disease models, toxicology species as well as the healthy and disease indication patient populations. This manuscript summarizes parameters that impact bioanalytical strategy for over 50 biotherapeutics indicated for the treatment of oncology, rheumatoid arthritis, allergy, multiple sclerosis, hematology, metabolism and infectious disease. We have addressed numerous therapeutic modalities including chimeric, humanized and fully human monoclonal antibodies, replacement proteins, peptides and fusion proteins, including polyethylene glycol and Fc fusions, as well as antibody-drug conjugates. With the rapid evolution of biotherapeutics over the last 20 years and the contraction of the pharmaceutical and biotechnology labor force, efficient workflow management becomes a crucial bioanalytical component. Thus, we have also addressed new technologies that have demonstrated either increased throughput or enhanced characterization, including Meso Scale Discovery, Gyrolab and affinity MS.
authors.affiliation: Bristol-Myers Squibb, Route 206 & Province Line Rd., Princeton, NJ 08540, USA. heather.myler@bms.com
authors.forename: Heather A
authors.initials: HA
authors.lastname: Myler
authors.forename: Allison
authors.initials: A
authors.lastname: Given
authors.forename: Karen
authors.initials: K
authors.lastname: Kolz
authors.forename: Johanna R
authors.initials: JR
authors.lastname: Mora
authors.forename: George
authors.initials: G
authors.lastname: Hristopoulos
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis*; D001688:Biological Products / Q000032:analysis*; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011994:Recombinant Proteins / Q000032:analysis
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins