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Developments and Challenges for mAb-Based Therapeutics
Pfizer, Pharmaceutical R&D – BioTherapeutics Pharmaceutical Sciences, 700 Chesterfield Parkway West, Chesterfield, MO 63017, USA
Alliance Protein Laboratories, 6042 Cornerstone Ct West, Suite A1, San Diego, CA 92121, USA
* Author to whom correspondence should be addressed.
Received: 23 May 2013; in revised form: 18 July 2013 / Accepted: 2 August 2013 / Published: 16 August 2013
Abstract: The continuous increase in the number of approved monoclonal antibody (mAb)-based therapy suggests that mAbs, and their derivatives, will continue to be the focus of the biotherapeutics industry for years to come. Although vast improvements in our capability to manufacture, characterize, and stabilize mAbs have been achieved, there are still challenges to be overcome. These include analytical and stabilization approaches associated with the development of high concentration mAb formulations. In addition, several mAb-based modalities are under development, including antibody drug conjugates (ADCs), fusion proteins, and bispecific antibodies (bsAbs), all designed to overcome the limitations encountered with mAb therapy. The current status of their development, with emphasis on manufacturing challenges as well as preliminary clinical results, will be reviewed.
Keywords: monoclonal antibody; fusion-proteins; antibody drug conjugates; fragments; bi-specific
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Goswami, S.; Wang, W.; Arakawa, T.; Ohtake, S. Developments and Challenges for mAb-Based Therapeutics. Antibodies 2013, 2, 452-500.
Goswami S, Wang W, Arakawa T, Ohtake S. Developments and Challenges for mAb-Based Therapeutics. Antibodies. 2013; 2(3):452-500.
Goswami, Sumit; Wang, Wei; Arakawa, Tsutomu; Ohtake, Satoshi. 2013. "Developments and Challenges for mAb-Based Therapeutics." Antibodies 2, no. 3: 452-500.