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Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation

School of Pharmacy, Faculty of Medicine and Health, The University of Sydney, Sydney 2006, Australia
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Antibodies 2019, 8(2), 36; https://doi.org/10.3390/antib8020036
Received: 16 April 2019 / Revised: 29 May 2019 / Accepted: 31 May 2019 / Published: 3 June 2019
(This article belongs to the Special Issue Monoclonal Antibody-Directed Therapy)
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. View Full-Text
Keywords: therapeutic antibody; stability; aggregation; manufacture challenges; formulation therapeutic antibody; stability; aggregation; manufacture challenges; formulation
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MDPI and ACS Style

Sifniotis, V.; Cruz, E.; Eroglu, B.; Kayser, V. Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation. Antibodies 2019, 8, 36.

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