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:

Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd

Len has over 30 years of experience in both industry and academia. Len has been a company founder, COO and GMP site head/license holder, overseeing biopharma development and manufacture as well as outsourced CDMO activities. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. Len’s regulatory and licensing experience covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large pharmaceutical companies. He is a member of a Regulatory working group, the ISPE and BIA

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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