Formulation and Delivery Issues for Monoclonal Antibody Therapeutics

  • Ann L. Daugherty
  • Randall J. Mrsny
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XI)


Therapeutic and diagnostic antibodies have become the fastest growing area of biopharmaceutical applications. There are now 18 monoclonal antibodies on the market and over 100 in clinical trials, which highlights the significance of these therapeutics and the advances made in antibody engineering. Further, by 2008, engineered antibodies are projected to be the source of over a third of the revenues from biotechnology (Baker 2005; Reichert et al. 2005).

A few seminal events that have led to the current and projected prominence of antibodies as biopharmaceuticals include the identification of methods to generate murine monoclonal versions of antibodies (Kohler and Milstein 1975), the cloning of human antibody sequences to allow for humanization of murine monoclonal antibodies through complementary-determining region (CDR) grafting (Jones et al. 1986), and even the establishment of fully humanized systems to generate monoclonal antibodies (Peterson 2005). With the sequential identification of these technological advances, antibodies for therapeutic and prophylactic indications have moved from fully murine, to partially murine (mostly human), and to completely human constructions. Added to these events, dramatic advances in production have led to the ability to prepare monoclonal antibodies at scales that can provide sufficient material at costs that make this area appealing to pharmaceutical companies. One important outcome of these various advances is a greater potential to use antibody drugs in chronic settings, tremendously expanding their biopharmaceutical applications.


Antibody Formulation PLGA Microsphere Gemtuzumab Ozogamicin Methionine Sulfoxide Antibody Drug 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



The authors wish to thank Reed Harris, Tom Patapoff, and Nancy Valente for their very insightful conversations and helpful suggestions. The review of the manuscript by Xanthe Lam, Brian Lobo, and Chung Hsu is appreciated. The references cited in this review were not intended to be inclusive of all of the seminal publications in the ever-expanding area of antibody stability and formulation. The relatively small numbers of references cited were selected to highlight specific aspects within the scope of this review. We regret that we could not cite many excellent publications that have made important contributions to this field.


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© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Genentech, Inc.South San FranciscoUSA
  2. 2.Department of Pharmacy & Pharmacology, Epithelial Cell BiologyUniversity of BathBathUK

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