Sebastian

Scheler

Managing Director

Innerspace

"Fast-Track to Robust Manufacturing: Case-Study from Frame-by-Frame Risk Profiling at Kindeva"Co-Founder at Innerspace | Managing Director | Chief Methodologist As the co-founder and leader of a multidisciplinary team of life science professionals and software developers at Innerspace, I am passionate about driving innovation through our Frame-by-Frame Technology—an automated solution for process modeling, risk assessment, and knowledge management. Our technology empowers organizations to automate and design processess, streamline operations, improve scalability, and mitigate risks in life science manufacturing processes. In my role as Managing Director and Chief Methodologist, I oversee the continuous development and optimization of this groundbreaking approach, ensuring it remains at the forefront of industry innovation. Additionally, I am proud to contribute as a trainer, delivering expert-led courses that enhance industry standards. My involvement in the PDA/Innerspace partnership allows me to actively shape the design and delivery of training programs, ensuring they meet the evolving needs of the life sciences sector. For process modeling, risk assessment and knowledge management: www.frame-by-frame.com

Panel Sypnosis

"Fast-Track to Robust Manufacturing: Case-Study from Frame-by-Frame Risk Profiling at Kindeva"Developing a robust fill-finish manufacturing process often requires complex, time-consuming iterations, with no guarantee of finding the lowest-risk, most scalable option. Manual process design and documentation create bottlenecks, hindering safety and automation efforts. This session will highlight a new approach using computer-generated, end-to-end process design, risk assessment, and documentation to streamline operations, reduce errors, and enhance scalability. The session will explore how risk reduction can be objectively measured to assess the actual robustness of the manufacturing process. It will also address how these measurements address the new requirements of ICH Q9(R1).