Process Development and Manufacturing

This session will focus on technologies associated with the future state of Fill-Finish manufacturing. The presentations in this session cover a wide variety of technologies such as innovative processes using modern technologies and intelligent modular concepts, the development of an innovative cGMP-compliant and flexible production cell based on isolator technology and technological highlights to cover major challenges for the aseptic handling of viral vaccines under BSL2.

This session will focus on three critical areas for successful tech transfer. The first presentation will provide insight to working with and establishing the right team for positive collaboration with a CDMO. The second presentation dives into a specific process and walks through steps to avoid common pitfalls in designing and transferring a cleaning process for manufacturing. The final presentation unlocks the concerns around continuous product and data flow from discovery through manufacturing exposing potential savings in time and costs.

This session discusses two topics in the landscape of modern modeling.  In the first, attendees will be exposed to new categories of DoE options and learn the potential advantages of these modern designs compared to classical designs.   The second topic focuses on the validation of AI applications.  A validation strategy based on an AI maturity model is described, including the benefits of  implementation of the maturity concept.

Focused on aseptic facilities and technologies, this session will take attendees through relevant and cutting edge topics currently affecting the production of parenteral products. Attendees will dive into the challenges which are often found in aging facilities and learn about strategies for the justification and execution of modernization projects.

At the forefront of digital transformation in the pharmaceutical industry, Data Analytics and AI are among some of the key technologies involved. What makes AI a foundational element for advanced process control in biomanufacturing? How does predictive maintenance become a reality in process intensive aseptic operations? What are some regulatory challenges involved? And how can risks associated with a Big Data infrastructure be mitigated to drive Operational Excellence? These are the questions being addressed in this session.