生物制剂和生物类似药:生产证书
的 生物制剂和生物类似药证书:制造 在 药学院 威尼斯赌场网站的主要研究方向是化学、制造和控制 (CMC) aspects 在 development and manufacture of biopharmaceutical products, preparing students for positions 在 industry and sharpening the skills and knowledge of those already working in this field. 这个证书是学校颁发的 法规事务(RA)和质量保证(QA)研究生课程 可以在网上找到. 获得此证书不需要硕士学位.
的 first biopharmaceutical product (recombinant human insulin) was approved in 1982, 从那时起, products derived through biotechnology have provided medical advances that include cell and gene therapies, 治疗性单克隆抗体, 癌症疫苗, 细胞因子, 反义技术, RNA干扰, 生长因子.
的 生物制剂和生物类似药:生产证书 enables students to become fluent 在 methods used 在 discovery of biopharmaceutical products, 包括材料采购和测试要求. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed. 教师 are drawn from the Food and Drug Administration (FDA) and the biopharmaceutical industry, 确保教授最新的发展和实践. 他们都是行业资深人士，在各自的专业领域拥有多年的专业知识, who share their considerable knowledge with students through classroom discussions and hands-on workshops.
Students who complete the 生物制剂和生物类似药证书:制造 sharpen their knowledge of this industry niche without committing to the entire master’s degree. Executive recruiters often seek candidates with demonstrated knowledge of the application of regulations to biologics and biosimilar manufacturing. 的 certificate provides students with credentials from Temple’s well-respected RA和QA研究生课程, giving them a solid grounding 在 issues surrounding biopharmaceutical manufacturing. 该证书对硕士申请者和毕业生开放, 谁可以用这个新证书扩大他们的职业机会.
学习目标
完成证书后，学生就会明白
-
更深层次的生物制剂和生物仿制药CMC策略
-
phase appropriate regulatory compliance elements applicable to biologics and biosimilars manufacturing;
-
生产生物制剂和生物类似药的主要步骤;
-
fundamentals of quality by design (QbD) as relevant to biologics and biosimilars manufacturing; and
-
fundamentals of statistical process control principles as relevant to biologics and biosimilars manufacture.
邮政局长的证书
Students have the option to complete a post-master’s curriculum in biologics and biosimilars manufacturing. This post-master’s certificate requires the completion of coursework focusing on how biologics and biosimilars are manufactured, 特别关注法规遵从性元素, QbD和统计过程控制的基础知识. 申请这个15学分的课程, applicants must hold a master’s degree in a 药店-related field and a bachelor of science degree in biology, 化学, 工程, 药店, 物理或相关领域.