07.13.26 -- Stream Advanced Delivery, GMP Scale-Up, & Annex 1 Compliance

Tailored drug release is rapidly evolving from a standard formulation tactic into a precision therapy strategy, optimizing timing, site, and rate of delivery to significantly improve patient outcomes.

What does it take to ensure performance and compliance in GMP manufacturing? We optimize single-use systems across upstream and downstream processes, ensuring they perform under GMP conditions.

Experts highlight spray drying as a gentle, scalable way to stabilize biologics, supporting high‑concentration injectables with controlled particles, sterility, and flexible delivery.

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 challenge and what it takes to close it.

This segment of the Outsourced Pharma Live event, “Beyond Data Packages: De-Risking Tech Transfer To CDMOs,” closes with practical advice for making tech transfer more predictable, including the value of digital process tools, video-based process capture, digital twins, and in silico models. 

Explore how advanced synthesis platforms, integrated CMC strategies, and scalable technologies are addressing complexity, cost, and regulatory demands.