先进生物疗法:生产和法规事务硕士 

的 高级生物治疗理学硕士:制造和法规事务 在 药学院 at PG电子试玩平台 launched in fall 2022 in collaboration with the Thomas Jefferson University’s Institute of Bioprocessing. 

而全球公司继续发现新的, 小分子治疗剂, 这是向大分子的重要转变, biopharmaceutical products as well as individualized medicine (advanced biotherapeutics) has been made possible due to new advances in the biotechnology and bioprocessing communities. 

最初专注于蛋白质替代和基于单克隆抗体的治疗, the profoundly rapid development and production of new therapeutics such as cell and gene therapies and COVID-19 vaccines based on messenger-RNA technology has further expanded the market and the need for a skilled and knowledgeable workforce. 

这种扩张影响到药物开发的各个方面, 包括制造技术, 分析方法和管理程序. 

PG电子试玩平台和托马斯·杰斐逊大学 

的 先进生物疗法:生产和法规事务硕士 program addresses the shortage of individuals trained in regulatory affairs and the manufacturing process of biotherapeutic agents. 的 degree unites the strengths of two regional institutions to provide an academic nexus for workforce development in the growing field of manufacturing and development of biologics and biosimilars. 

• PG电子试玩平台 法规事务(RA)和质量保证(QA)研究生课程 提供监管科学实践课程, 策略和质量保证期望, 为RA和QA的实际应用提供坚实的基础, 哪些对生物制药产品的开发和生产至关重要. 

• Thomas Jefferson University’s Institute of Bioprocessing offers didactic and 实验室-based courses providing students with valuable hands-on experience 在 development, manufacturing and analytical processes associated with the production of biopharmaceutical therapeutics. 的 courses are offered at the state-of-the-art Jefferson Institute located in the Spring House Innovation Park in Lower Gwynedd, 宾西法尼亚.

This groundbreaking master’s degree serves as a major vehicle for professional workforce development both locally and nationally. 的 curriculum combines theoretical and hands-on manufacturing process and analytical experience with mandated regulatory and quality assurance expectations that are essential to establishing and verifying good manufacturing, 实验室, 临床和药物警戒实践. 这个专业行业的起薪大约是9万美元. 

在托马斯·杰斐逊大学了解更多关于这个项目的信息. 

学习目标 

Students completing the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs should be able to demonstrate knowledge in the following areas.  

• 在美国有广泛的基础.S. 以及生物制剂和生物仿制药的全球监管格局 

• Regulatory strategies for nonclinical and clinical studies for biologics and biosimilar products 

• Chemistry, manufacturing and control (CMC) strategies for biologics and biosimilars 

• Phase-appropriate regulatory compliance elements applicable to biologics and biosimilars 

• Fundamentals of quality by design (QbD) and fundamentals of statistical process control principles as relevant to biologics and biosimilars manufacture 

• 掌握核心工程, 科学, regulatory and quality principles utilized in the development and manufacture of biopharmaceuticals, 生物制剂和先进疗法

• 生物制药生产业务, 包括生物反应器, 色谱法, 配方和产品浓缩操作 

• 过程开发概念，从早期到后期阶段的开发和发布

程序的格式 & 课程  

每所大学将提供自己的硕士学位，包括36个学分. Students will have the choice of receiving the MS in Advanced Biotherapeutics: Manufacturing and Regulatory Affairs from either PG电子试玩平台 or Thomas Jefferson University, 取决于他们感兴趣的领域. 

• 托马斯·杰斐逊大学的制造业 

• PG电子试玩平台的法规事务 

Students with a greater interest in the manufacturing process are required to submit a formal application for admission to Thomas Jefferson University, and students with a greater interest in regulatory affairs should submit a formal application for admission to PG电子试玩平台. In either instance the student will complete an informal nondegree-seeking application to the partner institution to enroll in courses and transfer or apply the required credits to their home school. 

• Each university will provide 15 credits of course work towards the MS degree (for a total of 30 credits between the two schools). 

• Students select the remaining six credits (of the required 36) based on their individual interest, 专注于杰佛逊的制造或天普的RA和QA原则. 

Students must complete 15 credits in Temple RA and QA courses (four courses are required and one is an elective).  

必修课程 

• 药物开发(5459) 

• 生物制剂/生物类似药:监管概述(5515)  

• 全球cmc -生物制剂(5577) 

• 疫苗:RA和QA方面(5572) 

选修课程

Students then choose at least one course from the following elective RA and QA courses. 

• 生物技术:生物过程基础(5471) 

• 医药生物科技(8005) 

• 统计质量控制(5451) 

• FUE(设施、公用事业和设备)的验证(5468) 

• 工艺验证(5474) 

• 先进优良生产规范-定义“c”(5479) 

• 无菌产品的生产(5492)  

• 灭菌程序(5493) 

• 无菌产品的开发(5501) 

• 药品生产中的微生物概念(5512)  

• 规管意见书(5514) 

• 清洁验证(5516) 

• 临床药物安全与药物警戒(5538*)  

• 监管情报(5544) 

• 上市后安全监察(5571*)   

• 质量体系管理(5574) 

• 法规科学:管理质量指南(5575) 

• 过程分析技术(PAT) (5625) 

• 实验统计设计(DOE) (5627) 

• 过程监控(5629) 

*学生可以选其中一门，但不能同时选两门. 

托马斯·杰斐逊大学生物加工学院的课程

Students must also complete a minimum of 15 credits in biopharmaceutical manufacturing from Thomas Jefferson University’s Institute of Bioprocessing, 包括以下必修课程. 

• 面向科学家的生物过程工程(engr609)  

• 生物制药和生物制品生产概论(engr621)

• 生物制药过程工程原理(engr611)  

• 生物制药工艺操作(engr604) ​

Students must take three more credits from the following Institute of Bioprocessing electives. 

• 上游单元操作介绍:细胞培养和收获(ENGR 601) 

• 下游装置操作简介:净化, 缓冲液交换和浓缩(engr602) 

• QbD，工艺选择和优化(engr605) 

• 载体与细胞系设计(engr613) 

• 生物治疗制剂(ENGR 622) 

• 疫苗配方(engr614) 

• 分析方法验证的技术和法规方面(ENGR 618) 

• 新兴疗法(ENGR 612) 

需求 

Students must have a science or engineering degree at the undergraduate or graduate level with an overall GPA of 3.0来追求MS.