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: Drugability Commercialization Biotherapeutics;Manufacturability;

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