This talk will delve into the intensification strategies being employed in mammalian cell culture to speed up the production process and improve yield. The session will cover techniques such as N-1 perfusion, seed culture optimization, and the use of larger flasks to reduce the number of bioreactors needed. Attendees will gain insights into how these strategies help overcome the physiological limitations of mammalian cell lines and reduce costs and risks associated with large-scale bioreactors.

• Understand the principles and benefits of process intensification.
• Explore different perfusion strategies and their applications.
• Learn about high seeding density techniques and their impact on productivity.
• Gain insights into media improvements for fed-batch and perfusion processes.

This session will look at both methods of biologic production and when, how and why to use them? What are the pros and cons to both and are they molecule dependent? Is there a clear winner and what will the future look like?

Cell culture media is arguably the most important and valuable component of a bioprocess. While use of commercially available basal and feed media is an option for some enterprises, biotherapeutic innovators must develop their own recipes for a variety of reasons including sourcing/supply chain and process control. While media development in the past has been focused on the application of fed-batch process, a workflow is also needed for designing media that can be used for intensified processes. A case study along with benefits and challenges that can be encountered with intensified bioprocess media development will be presented.

Cell culture process development is often limited by the turnaround time of spent media and of product quality analysis. Additionally, these methods are typically very complex requiring various SMEs to conduct the work. Here, we have assessed the Waters BioAccord instrument for its utility for streamlining these analyses to improve cell culture development timelines.

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• Innovations in HEK293 suspension cell cultures;
• Strategies to maximize AAV production yield;
• Regulatory considerations for CQAs in gene therapy;
• Overcoming challenges in process scale-up and technology transfer.

This talk will explore the critical challenge of optimizing the empty to full capsid ratio in AAV production. By examining various techniques such as plasmid engineering and feed studies, the session will provide insights into improving viral yield and product quality. The discussion will also cover innovative tools and analytical methods for early detection of capsid ratios in crude harvest materials, aiming to streamline the purification process and enhance overall efficiency.