Monday March 9 - PT (Pacific Time, GMT-08:00)
Intensified and continuous bioprocessing is no longer just a vision—it is rapidly becoming a reality across development and commercial manufacturing. This workshop will provide an in-depth exploration of the technologies, strategies, and case studies driving adoption of intensified upstream and downstream processes, as well as integrated continuous platforms.
Participants will gain insights into how companies are designing hybrid and fully continuous systems, leveraging PAT (process analytical technology) to enable real-time monitoring, and overcoming scale-up challenges. Discussions will highlight both the scientific and business advantages of these approaches: higher productivity, reduced costs, greater flexibility, and more sustainable operations.
Goals:
- Review state-of-the-art approaches in intensified and continuous processing for biologics and advanced therapies.
- Understand the technical, operational, and regulatory considerations in moving to continuous systems.
- Learn from real-world case studies of implementation and scale-up.
- Explore how continuous bioprocessing supports faster, more sustainable global access to medicines.
Process characterization is a regulatory requirement and a scientific imperative for developing robust, scalable, and compliant bioprocesses. This workshop will deliver practical tools and advanced strategies for designing and executing process characterization studies that generate actionable insights.
Experts will cover how to define CPPs (critical process parameters) and CQAs (critical quality attributes), apply risk-based approaches, and integrate statistical modeling and digital tools into the characterization framework. Attendees will also gain insights into regulatory expectations, accelerated development timelines, and how leading organizations are future-proofing their process characterization programs to align with evolving global requirements.
Goals:
- Provide proven methodologies for designing and executing effective process characterization studies.
- Share case studies demonstrating speed–quality balance in accelerated development.
- Explore regulatory perspectives on global alignment and expectations.
- Highlight emerging digital and statistical approaches that enhance process understanding.