Abstract
Therapeutic antibody technology heavily dominates the biologics market and continues to present as a significant industrial interest in developing novel and improved antibody treatment strategies. Many noteworthy advancements in the last decades have propelled the success of antibody development; however, there are still opportunities for improvement. In considering such interest to develop antibody therapies, this review summarizes the array of challenges and considerations faced in the design, manufacture, and formulation of therapeutic antibodies, such as stability, bioavailability and immunological engagement. We discuss the advancement of technologies that address these challenges, highlighting key antibody engineered formats that have been adapted. Furthermore, we examine the implication of novel formulation technologies such as nanocarrier delivery systems for the potential to formulate for pulmonary delivery. Finally, we comprehensively discuss developments in computational approaches for the strategic design of antibodies with modulated functions.
Highlights
Since the first therapeutic monoclonal antibody Orthoclone OKT3® (Janssen Biotech, Horsham, PA, USA) was approved by the USA Food and Drug Administration in 1986, whole antibody therapeutics have become and persistently remain the most dominant and significant biologic therapeutic platform in the pharmaceutical industry [1,2]
Whole therapeutic monoclonal antibody (mAb) are presently the dominant antibody platform approved for clinical use (Figure 1), antibody engineering technologies have advanced in recent years to produce highly optimized, strategically engineered biobetter therapies, along with biosimilar mAbs reaching market to compete against their originator
The characterization of mAb stability and target interaction for optimization is considered a fundamental step as part of preliminary drug discovery, as the applicability for development, manufacture, and formulation of the mAb therapeutic is governed by the mAbs stability profile
Summary
Since the first therapeutic monoclonal antibody (mAb) Orthoclone OKT3® (Janssen Biotech, Horsham, PA, USA) was approved by the USA Food and Drug Administration in 1986, whole antibody therapeutics have become and persistently remain the most dominant and significant biologic therapeutic platform in the pharmaceutical industry [1,2]. Whole therapeutic mAbs are presently the dominant antibody platform approved for clinical use (Figure 1), antibody engineering technologies have advanced in recent years to produce highly optimized, strategically engineered biobetter therapies, along with biosimilar mAbs reaching market to compete against their originator. Fragments of mAbs such as the crystallizable fragment (Fc), antigen binding fragment (Fab), and single-chain variable fragment (scFv) possess key functions such as specificity to a biological target or immunological activation The isolation of these fragments for fusion with other mAb fragments, biologically functional proteins, cytotoxic drugs, or drug carriers has been the crux of ingenuity in developing the generation of biobetter therapies [4,5,6,7,8,9,10,11,12,13,14,15].
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