Drugability Studies are Keys to the Successful Commercialization of Biotherapeutics
Jun Yuan1, Wayne W Xu2, Jing Wang2, Zach Kubin3, Wei-Jie Fang4 and H. Fai Poon2

1Zhejiang Hisun Pharmaceutical Co., Ltd., Zhejiang, China.

2Innova Med Biotechnology Co., Ltd., Guangdong, China.

3Shanghai ChemPartner Co., Ltd., Shanghai, China.

4Institute of Drug and Pharmaceutical Analysis, College of Pharmaceutical Sciences, Zhejiang University, Zhejiang, China.

Abstract: Successful therapeutic commercialization requires the demonstration of efficacy and safety of a drug during clinical trials, as well as the commercial feasibility of drug production with consistent quality. Mitigating risk in these three areas is the key strategy for pharmaceutical development success. One of the most effective ways of risk mitigation during therapeutic development is to perform drugability assessments of the molecule. Drugability assessment studies facilitate our understanding of biotherapeutics, predict clinical outcomes, and provide rationales for molecular optimization.  Better understanding of biotherapeutic drugability ensures the manufacturability, safety, and efficacy in clinical development. Therefore, drugability assessment is the key for successful biotherapeutic commercialization. Here, we reviewed  current literature, and summarized the major durability studies of biotherapeutics.

Keywords: Biotherapeutics; Manufacturability; Drugability Commercialization

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