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Flexible and Scalable Strategies for Upstream Vaccine Development and Manufacturing Supported by Integrated PAT

Vaccine pipelines are evolving to be more diverse and are requiring the use of different cell lines and virus types.  As the products vary, the manufacturing modes, process analytical needs, and volume requirements change along with the regulatory landscape. The need for scalable, flexible, and single-use process development tools and manufacturing strategies is becoming increasingly important. This webinar will highlight using Ambr® 15, Ambr® 250, Biostat RM, and Biostat STR along with integrated process analytical technologies (PAT) to go from high throughput process development to an intensified seed train and manufacturing platform.

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Vaccine specific case studies will be shown for the Ambr® 15 and Ambr® 250 looking at different suspension and adherent cell lines. Using various combinations of rocking motion (RM) and stirred tank bioreactors (STR) allows for various seed train and manufacturing scenarios using fed-batch, intensified, or perfusion cultures. Throughout the process, various PAT tools like at-line glucose measurements, viable cell density monitoring, and spectroscopy are implemented for enhanced process monitoring and control. This complete single-use upstream toolbox allows for rapid development and scale-up to manufacturing of vaccine processes at a lower cost and resource requirement compared to the legacy multi-use vessel approach.

Key Learning Objectives

  1. Overview of Sartorius upstream technologies that can be used in vaccine development and production, Scalability of processes from Ambr to Biostat STR, Highlighting the importance of PAT for advanced monitoring and control of vaccine processes
  2. Sartorius provides a complete set of scalable upstream single-use technologies for vaccines from development to commercial manufacturing.  All bioreactors in our portfolio can be flexibly operated for various cell lines and processes.  The Sartorius PAT toolbox can be used at all scales for at-line or in-line monitoring and control

Meet Our Experts

Melisa Carpio

Global Technology Consultant

Melisa is a Global Technology Consultant at Sartorius. In this role, she focuses on the growth and development of the Biostat® STR product line. She works to continually investigate opportunities for new product enhancements, collaborations, and applications. Prior to Sartorius, Melisa spent nine years working in the industry doing cell engineering and cell line development at Genitope, MedImmune, and Takeda. She holds a BS and MS in Chemical Engineering from the University of California, Berkeley.

Kevin McHugh

Global Technology Expert

Kevin McHugh is a Global Technology Expert in the Cell Culture Technologies department at Sartorius, who focuses on the Ambr® product line. He has worked on multi-parallel bioreactors for over 6 years, joining TAP Biosystems as a Product Specialist. In his current role Kevin works to shape the development and direction of the Ambr® product line. He explores technology integrations, investigates technology developments, and examines new application areas for the Ambr product line. Prior to Sartorius, Kevin spent 6 years working in the industry at Glaxo Smith Kline and Sanofi Pasteur where he focusing microbial process development, evaluating and implementing new technologies, developing and optimize scaling models. He holds a B.S. in Bioengineering from Lehigh University.

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