Introduction to Biopharmaceutical Manufacturing

Description

This course introduces the manufacturing process and common unit operations used in the manufacture of biopharmaceuticals. Starting with an industry overview that provides insight into what drives Process Development and Manufacturing, the course then moves through expression systems, protein characterization, fermentation/cell culture, recovery, purification, formulation, fill and finish. The course will follow with facility design, construction and start up, and key parameters for scaling up with industry examples. The course concludes with the role of quality and the regulatory environment under which biologicals are produced, including validation. This course is designed to introduce you to the language of manufacturing, provide a perspective on the operations that make up a manufacturing process, and help you understand how a process works to produce safe and effective products.

Instructor

Marilee Brooks, P.E. Industry Consultant
Marilee Brooks has over 15 years experience in biopharmaceutical operations. She headed up the Manufacturing Science Group at Chiron Corporation, which executed several successful Technology Transfers from in-house Process Development and from contract manufacturing clients into large-scale cGMP production. She was involved in the generation of the Manufacturing section of the CMC is several successful FDA filings. Currently she is involved with University of California, Berkeley's Initiative for Research on Biopharmaceuticals Operation (IRBO) that focuses on Operational research collaborations between academia and industry. She holds a Masters degree in chemical engineering from the University of California, Berkeley.

Course Agenda

• Introduction to the biopharmaceutical manufacturing industry
• Protein basics and analytical methods for characterization
• Expression systems: microbial and mammalian
• Cell banking: master and working cell banks
• Fermentation: culture methods and key process parameters
• Cell culture: culture methods and key process parameters
• Recovery methods: centrifugation and cell breakage
• Filtration: microfiltration, ultrafiltration and diafiltration
• Purification: fundamentals of chromatography
• Ion exchange, reversed phase, hydrophobic interaction and affinity
• Formulation, aseptic filling and lyophilization
• Process development and scale up, with large scale examples
• Facility design and monitoring
• Current Good Manufacturing Practice (cGMP)
• Inspections and working with the FDA
• Validation: equipment, facility, process, viral clearance