Common Sense Continuous: Simplifying Integrated GMP Operations

Unlock a practical path to continuous, compliant GMP operations with single-use perfusion and fully connected downstream processing. See how high-cycle, small sub-batches generate richer data, de-risk validation, and accelerate speed, consistency, and scalability.

Register Free: https://www.pharmtech.com/pt_w/common-sense

Event Overview:

As biologics move from fed-batch norms to continuous bioprocessing, traditional approaches to process characterization and validation are no longer enough. To achieve robust, scalable processes that endure through a therapy’s life cycle and enable commercialization, control strategies must evolve.

In this session, FUJIFILM Biotechnologies experts will share how the MaruX™ platform—single-use bioreactors run in perfusion with a fully connected downstream composed of single-use SymphonX™ units—enables a new paradigm. By defining processes in high-cycle, small sub-batches, teams can generate richer data and de-risk validation in continuous operations.

Join us to see how next-generation process design unlocks speed, consistency, and compliance for continuous bioprocessing.

Key Learning Objectives:
In this webinar you will learn about:

• Drivers for continuous biomanufacturing
• Definitions of continuous and operational impact
• Common Sense Continuous in line with ICH Q13 and its benefits
• FUJIFILM Biotechnologies’ qualification and validation approaches for continuous cGMP operation

Who Should Attend:

• Pharmaceutical manufacturing
• Large biotech, spinouts
• Anyone with CMC/late phase or procurement in their titles
• Technical directors and above
• CSOs
• Heads of science and above
• Consultants
  

Speaker:

Charles Heise
Associate Director (BioProcess Strategy & Development, Process Development)
FUJIFILM Biotechnologies

Charles Heise is the associate director in the Bioprocessing Strategy & Development group at FUJIFILM Diosynth Biotechnologies, developing connected, integrated processes. He has over 15 years of experience in the biologics industry leading the development of cGMP processes for clinical and commercial recombinant protein manufacture and academic research collaborations. He is coinventor of the award-winning SymphonXTM purification skid and the downstream technical lead for FDB’s continuous biomanufacturing platform, MaruXTM. Heise graduated from the University of Oxford and obtained his doctorate from the University of York.

Jonathan Rapley
Director, Process Validation
FUJIFILM Biotechnologies

Jonathan Rapley is the director of process validation sciences at FUJIFILM Diosynth Biotechnologies, where he leads process validation strategy for complex global biologics programs. With over 12 years of experience spanning process development, technology transfer, process characterization, PPQ, and commercial life cycle validation, he has supported mammalian and microbial biologics, biosimilars, and vaccines from development through commercial manufacture. Rapley has extensive experience in regulatory expectations, control strategy development, and risk-based validation and has led global harmonization initiatives across multiple sites. He is passionate about applying practical, science-based approaches to process validation that are robust, pragmatic, and inspection-ready.

Register Free: https://www.pharmtech.com/pt_w/common-sense