Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
This course introduces participants to the process of developing biopharmaceuticals starting with the gene of interest and ending with a commercial product. The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics. The need for Quality by Design in all aspects of biopharmaceutical development will be emphasized. Lastly, we’ll highlight the differences between small molecules and biomolecules (large molecules). The purpose of this course is to provide a fundamental understanding of the CMC aspects of biopharmaceuticals from development to market.
This training course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.