期刊
JOURNAL OF PHARMACEUTICAL SCIENCES
卷 109, 期 1, 页码 30-43出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2019.08.010
关键词
protein delivery; immunogenicity; monoclonal antibody(s); biosimilar(s); formulation; macromolecular drug delivery; oligonucleotide(s); gene delivery
In 2003, Crommelin et al. published an article titled: Shifting paradigms: biopharmaceuticals versus low molecular weight drugs (https://doi.org/10.1016/S0378-5173(03)00376-4). In the present commentary, 16 years later, we discuss pharmaceutically relevant aspects of the evolution of biologics since then. First, we discuss the increasing repertoire of biologics, in particular, the rapidly growing monoclonal antibody family and the advent of advanced therapy medicinal products. Next, we discuss trends in formulation and characterization as well as summarize our current insights into immunogenicity of biologics. We spend a separate section on new product(ion) paradigms for biologics, such as cell-free production systems, production of advanced therapy medicinal products, and downscaled production approaches. Furthermore, we share our views on issues related to reaching the patient, including routes and techniques of administration, alternative development models for affordable biologics, biosimilars, and handling of biologics. In the concluding section, we outline outstanding issues and make some suggestions for resolving those. (C) 2020 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据