Biotechnology

Using case studies and exercises this course in facility design provides an overview of the concepts utilized in the development and renovation of sound designs for facilities that manufacture biopharmaceutical products. The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements. Immediately apply the course objectives using the electronic....

This course provides a comprehensive understanding of biotech manufacturing processes - what makes biopharmaceutical processes different from small molecules. Course content explores the underlying principles of proteins and cells to provide the foundation for how and why processes manufacture therapeutic proteins. The course studies commonly used manufacturing process operations including cell culture and fermentation; harvest and recovery; viral removal and inactivation; purification processes such as tangential flow filtration, centrifugation, size exclusion and adsorptive chromatography. Course topics include: Biotechnology basics Identify and discuss important operating parameters for each bioprocess unit operation and how they impact process performance What parameters are important....

The inherent complexity and uncertainty of biotechnology make developing and validating bioprocesses for manufacturing proteins and biopharmaceuticals very difficult. Understanding and using FDA's Process Validation Guideline is critical to establishing and maintaining control of complex processes, as well as achieving regulatory approval of new products. This classroom course is designed to provide a clear understanding of the regulatory, scientific, and engineering tools required to successfully develop and validate bioprocesses . In addition, the course identifies the long list of activities required to validate biopharmaceutical processes. Topics include a comprehensive strategy to process validation; a review of important biotechnology manufacturing processes,....

This fundamental course is ideal for professionals that are new to the biotechnology industry, professionals entering new work assignments encompassing biotechnology operations or individuals with previous pharmaceutical industry experience that want to learn the basics of biotechnology . This is a course that is ideal for individuals involved in human resources, economic development, and business and strategic planning efforts. Professionals in quality control, quality assurance, and technical management support will also find it beneficial. Participants in this classroom course will explore the history of the biotechnology industry and will learn the fundamental concepts of biotechnology science. Participants will also learn....