کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2484587 1114319 2015 14 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Developability Assessment During the Selection of Novel Therapeutic Antibodies
ترجمه فارسی عنوان
ارزیابی قابلیت توسعه در هنگام انتخاب آنتی بادی های رمان پزشکی
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
چکیده انگلیسی
Therapeutic antibodies and antibody derivatives comprise the majority of today's biotherapeutics. Routine methods to generate novel antibodies, such as immunization and phage-display, often give rise to several candidates with desired functional properties. On the contrary, resource-intense steps such as the development of a cell line, a manufacturing process, or a formulation, are typically carried out for only one candidate. Therefore, "developability," that is, the likelihood for the successful development of a lead candidate into a stable, manufacturable, safe, and efficacious drug, may be used as an additional selection criterion. Employing a set of small-scale, fast, and predictive tests addressing biochemical and biophysical features, as well as in vivo fate can help to identify a clinical candidate molecule with promising properties at an early stage of drug development. This article gives an overview of existing methods for developability testing and shows how these assays can be interlaced in the lead selection process.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 104, Issue 6, June 2015, Pages 1885-1898
نویسندگان
, , , , , ,