Continuous manufacturing of biologics has been an area of active research and development. Moving from batch or fed-batch upstream processing to a continuous perfusion process requires more sophisticated modular controllers, automation strategy, bioreactor systems, as well as one single medium used within all process stages. In today’s Knowledge Culture Basics Education Series on perfusion, we will explain what perfusion is, the overall perfusion process, and best practices for perfusion media evaluation followed by the brief introduction of Gibco High-Intensity Perfusion Medium and DynaDrive Single-Use Bioreactor.
Learning Objectives
- What is perfusion? Why use it?
- Overall perfusion process: types of perfusion, planning a perfusion run, hardware needs for perfusion, and perfusion medium selection and testing
- Best practices for perfusion medium evaluation
- Gibco High-Intensity Perfusion (HIP) CHO Medium and DynaDrive Single-Use Bioreactor
Speaker
Garima Mishra
Field Applications Staff Scientist for Cell Culture/Cell Therapy (CC/CT) in BioProduction Group (BPG), supporting the Asia Pacific and Japan (APJ) region
Garima is an experienced biotechnology professional with over 15 years of career in biologics drug development. Her key expertise covers chemistry manufacturing and control (CMC) including cell line engineering and development, early-stage process development, analytics, and product development. She has established Quality by Design (QbD)-based workflows for in-house cell line development and early-stage development (ESD). Garima is Molecular and Cell Biologist by training and she has worked in the manufacturing sciences and recombinant protein production by driving innovation in both technologies and workflows throughout the development of product pipeline. She has led early-stage development teams for partnered and in-house projects. She has authored technical reports for relevant CMC sections of IND and BLA and was involved in dossier preparation for biologics drug application. She has worked on various projects involving cross functional teams including R&D, Manufacturing, Quality Control, Quality Assurance, Legal, IPR and Program Management. She has bachelor’s degree in Biology from Agra University, and Master of Science in Biochemistry from Bangalore University. Prior to joining Thermo Fisher Scientific, Garima has held R&D roles in Biocon, Pfizer Biologics, Dr. Reddy's Laboratory, and Reliance Life Science.