10.05.26 -- STREAM: GMP Strategy, AAV Analytics & Biologics Scale-Up

Develop lower-risk conjugation strategies by incorporating the critical insights we highlight in our review of semi-synthetic versus synthetic linker–payloads and their respective advantages and limitations.

Explore how to implement analysis using sedimentation velocity analytical ultracentrifugation to characterize AAV size distributions and multiple detection wavelengths to identify fill states in AAV preparation.

See how flexible single-use manufacturing strategies can accelerate scale-up, improve efficiency, and help streamline the journey from clinical development to commercialization.

Led by Dr. Richard Johnson, Chief Scientific Officer, this 40-minute session covers the five key stages of the UpperNose development platform, highlighting the significance of target product selection and its influence on formulation and clinical outcomes.

Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer.

Learn how GS Effex® integrates into our GS Gene Expression System®, letting customers use the same expression vectors, GS piggyBac® transposase technology, and media while incorporating the cell line into existing workflows.