Biologics and Biosimilars: Manufacturing Certificate
The Certificate in Biologics and Biosimilars: Manufacturing in the at 51动漫 focuses on chemistry, manufacturing and control (CMC) aspects in the development and manufacture of biopharmaceutical products, preparing students for positions in the industry and sharpening the skills and knowledge of those already working in this field. This certificate is part of the school鈥檚聽聽and is available online. A master鈥檚 degree聽is not required to earn this certificate.
The first biopharmaceutical product (recombinant human insulin) was approved in 1982, and since then, products derived through biotechnology have provided medical advances that include cell and gene therapies, therapeutic monoclonal antibodies, cancer vaccines, cytokines, antisense technology, interference RNA, and growth factors.听
The Biologics and Biosimilars: Manufacturing Certificate enables students to become fluent in the methods used in the discovery of biopharmaceutical products, including materials sourcing and testing requirements. Technologies and unique considerations associated with the manufacture of biopharmaceutical products are discussed. Faculty are drawn from the Food and Drug Administration (FDA) and the biopharmaceutical industry, ensuring that the latest developments and practices are taught. They are industry veterans with years of expertise in their specialties, who share their considerable knowledge with students through classroom discussions and hands-on workshops.听聽
Students who complete the Certificate in Biologics and Biosimilars: Manufacturing sharpen their knowledge of this industry niche without committing to the entire master鈥檚 degree. Executive recruiters often seek candidates with demonstrated knowledge of the application of regulations to biologics and biosimilar manufacturing. The certificate provides students with credentials from 51动漫鈥檚 well-respected RA and QA graduate program, giving them a solid grounding in the issues surrounding biopharmaceutical manufacturing. The certificate is open to both MS applicants and graduates, who can expand their career opportunities with this new credential.
Learning Objectives聽
Upon completion of the certificate, students will understand聽
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CMC strategies for biologics and biosimilars at a deeper level;聽
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phase appropriate regulatory compliance elements applicable to biologics and biosimilars manufacturing;聽
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major steps involved in the manufacture of biologics and biosimilars;聽聽
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fundamentals of quality by design (QbD) as relevant to biologics and biosimilars manufacturing; and
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fundamentals of statistical process control principles as relevant to biologics and biosimilars manufacture.听聽
Post-master鈥檚 Certificate
Students have the option to complete a post-master鈥檚 curriculum in biologics and biosimilars manufacturing. This聽post-master鈥檚 certificate聽requires the completion of coursework focusing on how biologics and biosimilars are manufactured, looking specifically at regulatory compliance elements, fundamentals of QbD聽and statistical process control. To apply for this 15-credit program, applicants must hold a master鈥檚 degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields.
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