Biologics and Biosimilars: Manufacturing Certificate

的 Certificate in Biologics and Biosimilars: Manufacturing 在 药学院 at PG电子试玩平台 focuses on 化学, manufacturing and control (CMC)方面的生物制药产品的开发和制造, 为学生在该行业的职位做好准备，并提高已经在该领域工作的人的技能和知识. This certificate is part of the school’s regulatory affairs (RA) and quality assurance (QA) graduate program and is available online. A master’s degree is not required to earn this certificate.

首个生物制药产品(重组人胰岛素)于1982年获批, 从那时起, 通过生物技术衍生的产品带来了包括细胞和基因疗法在内的医学进步, therapeutic monoclonal antibodies, 癌症疫苗, 细胞因子, antisense technology, RNA干扰, 生长因子. 

生物制剂和生物仿制药:制造证书使学生能够熟练使用发现生物制药产品的方法, including materials sourcing and testing requirements. 讨论了与生物制药产品制造相关的技术和独特考虑因素. 教师来自食品和药物管理局(FDA)和生物制药行业, ensuring that the latest developments and practices are taught. 的y are industry veterans with years of expertise 在ir specialties, 谁通过课堂讨论和实践研讨会与学生分享他们丰富的知识.  

完成生物制剂和生物仿制药证书:制造的学生无需完成整个硕士学位，即可提高他们对该行业利基的知识. 行政招聘人员经常寻找具有生物制剂和生物仿制药生产法规应用知识的候选人. 该证书为学生提供了来自PG电子试玩平台备受尊敬的证书 RA和QA graduate program，为他们在生物制药制造问题上打下坚实的基础. 的 certificate is open to both MS applicants and graduates, who can expand their career opportunities with this new credential.

学习目标 

Upon completion of the certificate, students will understand 

  • CMC strategies for biologics and biosimilars at a deeper level; 

  • 适用于生物制剂和生物仿制药生产的阶段性法规遵从要素; 

  • major steps involved 在 manufacture of biologics and biosimilars;  

  • fundamentals of quality by design (QbD) as relevant to biologics and biosimilars manufacturing; and

  • 与生物制剂和生物仿制药生产相关的统计过程控制原理的基础知识.  

Post-master’s Certificate

学生可以选择完成生物制剂和生物仿制药制造的硕士后课程. 该硕士后证书要求完成关于生物制剂和生物仿制药如何制造的课程, looking specifically at regulatory compliance elements, fundamentals of QbD and statistical process control. To apply for this 15-credit program, 申请人必须持有药学相关领域的硕士学位和生物学学士学位, 化学, 工程, 药店, physics or related fields.

了解更多关于生物制剂和生物仿制药:制造硕士后证书的信息.

Regulatory Affairs and Quality Assurance at the 药学院 

For over five decades, PG电子试玩平台’s 药学院 has provided outstanding graduate-level coursework in RA和QA. 

的 药学院  

  • pioneered RA和QA graduate education in 1968, 开设第一个RA和QA在线学位课程，并提供最全面的RA和QA课程;   

  • has outstanding expert faculty from industry and the U.S. 美国食品和药物管理局(FDA)，确保教授最新的发展和实践; 

  • attracts students from the biopharmaceutical, 医疗设备, pharmaceutical and related industries (cosmetics, food and healthcare); 

  • 安排现场课程，在晚上和周末进行互动讨论和研讨会; 

  • has hundreds of students from across the country, facilitating great networking opportunities; and 

  • provides individualized services to students.    

证书提供坦普尔备受尊敬的RA和QA研究生课程的证书, which can be applied to the RA和QA master’s degree. 

程序的格式 & 课程  

It is strongly suggested that students have a bachelor’s degree in biology, 化学, 工程, 药店, physics or related fields from an accredited institution of higher learning. However, a degree 在 sciences is not required.

生物制品和生物仿制药证书:可以自己获得，也可以在获得证书的过程中获得 RA和QA MS 或者是 Advanced Biotherapeutics: Manufacturing and Regulatory Affairs MS, 由PG电子试玩平台药学院和坎巴尔设计学院合作开设, Engineering and Commerce at Thomas Jefferson University. To earn the certificate, 四年内必须修完五门课程，总成绩必须达到B (3).0)平均. 

Students must complete the following four required courses. 

  • Biotechnology: Bioprocess Basics (RAQA 5471)具有先前教育或生物制剂生产经验的学生可以从以下选修课列表中选择一门课程来代替本课程. 

  • Biologics/Biosimilars: A Regulatory Overview (RAQA 5515)具有先前教育或生物制剂监管经验的学生可以从以下选修课中选择一门课程来代替本课程. 

  • Global CMCs—Biopharmaceuticals and Other Biologics (RAQA 5577) 

  • Pharmaceutical Biotechnology (8005) 

Students must also complete one elective from the following courses. 

  • Statistical Quality Control (RAQA 5451) 
  • Validation of FUE (Facilities, Utilities, and Equipment (RAQA 5468) 
  • Process Validation (RAQA 5474) 
  • Advanced Good Manufacturing Practices—Defining “c” (RAQA 54 79) 
  • Production of Sterile Products (RAQA 5492) 
  • Sterilization Processes (RAQA 5493) 
  • Development of Sterile Products (RAQA 5501) 
  • Microbiological Concepts in Pharmaceutical Manufacturing (RAQA 5512) 
  • Cleaning Validation (RAQA 5516) 
  • Vaccines: RA和QA Issues (RAQA 5572) 
  • Statistical Design of Experiments (DOE) (RAQA 5627) 
  • Process Monitoring (RAQA 5629) ​

All courses must be completed from PG电子试玩平台’s RA和QA graduate program. No transfer credits from other institutions are accepted. If a student has completed an identical course at an accredited U.S. 研究生院, 学生可以申请RA和QA项目放弃该课程，并选修另一门经批准的选修课程. 这一要求必须以书面形式提出，并在学生攻读证书之前获得批准. 

Learn more about the Biologics and Biosimilars: Manufacturing Certificate.

参见课程设置. 

需求 

  • Candidates must formally apply and follow the application procedures (application form, photocopies of transcripts and Notice of Completion). 

  • 在学生获得硕士学位之前，只能完成一个证书课程.

  • 学生必须在四年内完成证书，课程可以在线完成. 学生必须在完成所有课程要求的一年内申请证书. 

  • 有兴趣攻读RA和QA硕士学位的学生可以将证书中获得的所有学分用于研究生学位, 前提是他们正式申请硕士课程并被PG电子试玩平台录取 研究生院.

Learn more about the application process.

Related 研究生 Degrees

学费 & 费用

In keeping with Temple’s commitment to access and affordability, 该项目提供有竞争力的学费水平，并提供多种经济支持机会.

学费 rates are the same, whether courses are online, 校园, 证书课程的一部分或药学院另一个硕士课程的一部分.

Per course for Pennsylvania residents: $3,393
Per course for nonresidents: $4,218

PG电子试玩平台的学费每年由学校设定，并受多种因素影响, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, 和更多的.

You can view the full Cost of Attendance breakdown on the Student Financial Services website.

认证

PG电子试玩平台’s departments and programs are accredited by the Middle States Commission on Higher Education.

PH-BBMN-GRAD

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