Bioanalytical challenges and unique considerations to support pharmacokinetic characterization of bispecific biotherapeutics

Author:

Ma Mark1,Colletti Kelly2,Yang Tong-Yuan3,Leung Sheldon4,Pederson Susan5,Hottenstein Charles S6,Xu Xiaohui7,Warrino Dominic8,Wakshull Eric9

Affiliation:

1. Alexion Pharmaceuticals, 100 College Street, New Haven, CT 06443, USA

2. Charles River Laboratories, 6995 Longley Lane, Reno, NV 89511, USA

3. Janssen BioTherapeutics, Janssen Research & Development, LLC,1400 McKean Road, Spring House, PA 19477, USA

4. Selecta Biosciences, Inc., 480 Arsenal Way, Watertown, MA 02472, USA

5. Alder BioPharmaceuticals, Bothell, WA 98011, USA

6. GlaxoSmithKline Pharmaceuticals Research & Development, 1250 South Collegeville Road, Collegeville, PA 19426, USA

7. Bristol-Myers Squibb, Route 206 & Provinceline Road, Princeton, NJ 08543, USA

8. KCAS Biopharmaceutical & Biomarker Services , 12400 Shawnee Mission Parkway, Shawnee, KS 66216, USA

9. Genentech,1 DNA Way, South San Francisco, CA 94080, USA

Abstract

Compared with conventional (monospecific) therapeutics, bispecific protein therapeutics present unique challenges for pharmacokinetic (PK) characterization – namely, the characterization of multiple functional domains as well as the consideration of biotransformation or interference by the formation of antitherapeutic antibodies against each functional domain. PK characterization is essential to the success of the overall drug development plan and for molecules with multiple binding domains; multiple bioanalytical methods may be needed to answer critical questions for each phase of drug development. The number of bispecific protein therapeutics entering drug development continues to increase, and therefore, a bioanalytical strategy for the PK characterization of bispecific molecules and study of their in vivo structure–function relationship is needed. This review presents case studies and a regulatory perspective.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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