Monday March 9 - PT (Pacific Time, GMT-08:00)
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.
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
The COVID-19 pandemic and ongoing global pressures have highlighted the fragility of biopharmaceutical supply chains. This workshop will explore how companies are rethinking their supply-chain models for both clinical and commercial supply to ensure continuity, scalability, and resilience.
Industry leaders will address key challenges such as raw material shortages, supplier diversification, just-in-time vs. just-in-case inventory strategies, and the use of digital visibility platforms to improve forecasting and risk management. Special focus will be given to advanced therapies, where supply-chain requirements for personalized products create unique logistical hurdles.
Goals:
- Examine strategies for supply-chain resilience in an unpredictable global environment.
- Understand unique requirements for clinical vs. commercial supply chains.
- Learn how advanced analytics and digital platforms are transforming supply visibility.
- Gain best practices for building strategic supplier partnerships and mitigating risk.