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
Sue Behrens, Ph.D., Independent Consultant; former Senior Director, Vaccines & Biologics, Merck Manufacturing Division
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
