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:

Developing safe and effective lipid nanoparticle (LNP) and liposomal therapeutics depends on accurate characterization of critical quality attributes throughout development and manufacturing.

In this webinar, we'll review evolving regulatory expectations from the FDA, EMA, and USP and discuss why attributes such as particle size, size distribution, surface charge, and particle morphology are essential for product quality. We'll then introduce field-flow fractionation coupled with multi-angle light scattering (FFF-MALS) as a versatile analytical platform that provides size-resolved characterization while preserving native particle structure.

Through practical examples and implementation guidance, attendees will learn how FFF-MALS can strengthen analytical workflows and support regulatory-ready characterization.

Key Learning Objectives:

• Review recent and upcoming regulatory changes affecting LNP and liposomal drug critical quality attributes.
  
• Learn how FFF‑MALS can address critical quality attributes.
  
• Discover resources and practical tips for implementation.

Who Should Attend:

This webinar is designed for scientists, analysts, and lab managers working on vaccine, lipid nanoparticle (LNP), or liposome characterization, as well as professionals at CDMOs, CROs, and testing organizations looking to expand their analytical capabilities.

Speakers:

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