Journal
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY
Volume 43, Issue 4, Pages 519-530Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/03639045.2017.1278768
Keywords
Monoclonal antibodies; FDA approval; high-efficiency delivery; pharmaceutics; stable formulation
Categories
Funding
- Science and Technology Program of Shandong Colleges and Universities [J15LM65]
- Major Scientific Project of Jining Medical College [JY2013KJ009]
Ask authors/readers for more resources
Monoclonal antibodies (mAbs) are extensively employed for disease diagnosis and treatment because of their high homogeneity and antigen specificity. In recent years, important outcomes have been achieved with mAbs due to their admirable therapeutic efficacy and relatively rare side effects. In clinical practice, several mAb products have been approved by regulatory entities, but their formulations have been highly specific given the complex structure and proteinaceous nature of mAbs. Thus, more attention has been given on formulations. An increasing number of novel delivery systems have been exploited to optimize the application of mAbs. In this article, the formulations, dosages, origins and administration routes of available mAbs approved by the Food and Drug Administration (FDA) are summarized and categorized. Key issues involved in formulation, processing and storage are addressed as well as other challenges in achieving effective mAb delivery. Finally, recent advances in delivering mAbs in their most bioavailable forms are also briefly reviewed.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available