Advanced Training in Mammalian Cell Culture and Bioreactor Operations

Introduction:

Mammalian cell culture plays a crucial role in the production of biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and cell and gene therapies. This advanced training program offers a comprehensive overview of best industry practices in mammalian cell culture and bioreactor operations, covering topics such as media development, cell line development, process monitoring and control, and advanced techniques. Through a combination of theoretical learning and practical application, participants will gain the knowledge and skills necessary to optimize productivity, efficiency, and product quality in mammalian cell culture processes.

Trainer Profile:

Hugo Federico Cueto Rojas, Associate Director / Team Lead Drug Substance Development, uniQure

Hugo has over 15 years of experience in both industry and academia in process development with particular focus on animal cell culture and precision fermentation. He has ample experience in Cell Line Development, scale up/down of upstream processes, high-throughput experimentation, automation and control of cell culture operations, media optimization, cell culture intensification, PAT, first-principles and empirical modeling to aid process development. He has worked with a wide variety of cell lines (e.g. HEK293-derived and Sf9-derived) and microorganisms such as cyanobacteria, hydrogenotrophs, S. aureus, E. coli, and S. cerevisiae.

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Methodology

The training program will utilize a combination of lectures, case studies, workshops, and interactive discussions to facilitate active learning and engagement. Participants will have opportunities to apply theoretical knowledge to practical challenges through problem-solving exercises and collaborative activities. The course will be delivered by a sought-after upstream subject matter expert in mammalian cell culture and bioreactor operations.

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Key Outcomes

Upon completion of the course, participants will:

• Gain a comprehensive understanding of best industry practices for mammalian cell culture, including bioreactor operations and perfusion culture

• Acquire practical skills for media development, cell line development, and process optimization

• Learn about advanced techniques and technologies in mammalian cell culture, including single-use systems and Quality by Design (QbD) principles

• Enhance interdisciplinary collaboration and communication skills to facilitate successful implementation of mammalian cell culture processes

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Who Should Attend?

This training program is essential for professionals involved in biopharmaceutical manufacturing, including:

• Cell Culture Scientists and Engineers
• Process Development Specialists
• Bioprocess Engineers
• Researchers and Scientists in R&D
• Manufacturing Professionals
• Quality Assurance/Quality Control Specialists
• Regulatory Affairs Professionals
• Project Managers

Schedule:
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DAY 1:
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Session 1: Introduction to Mammalian Cell Culture

14:00 - 15:00 Title: Mastering the Basics: Fundamentals of Mammalian Cell Culture
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Summary:

• Overview of mammalian cell types used in biopharmaceutical production
• Introduction to cell culture techniques and media formulations
• Key considerations for maintaining cell viability and productivity

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Session 2: Bioreactor Design and Operation

15:00 - 16:00 Title: Engineering Success: Bioreactor Design and Operation for Mammalian Cell Culture
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Summary:

• Overview of bioreactor systems used in mammalian cell culture
• Design considerations for optimal cell growth and productivity
• Operating parameters and strategies for bioreactor control

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16:00 - 16:15 Coffee Break