Disposables - Early Phase / Clinical Manufacturing Approach Utilization Disposable Applications (Session 501)

Wednesday 9 November 08.15 – 12:00

ISPE CEUs: 0.35

In these circumstances, disposable technologies may have greater application for high throughput, low cost clinical screening of potential drug candidates. There are a number of issues that need to be resolved for Phase 0/1 production. This seminar will address the following: Compatibility issues, component interchangeability, supply chain risk, integrity of disposable systems and environmental monitoring challenges; advances in technologies for downstream processing; development of a combined roadmap for successful implementation from phase one to commercial manufacturing.

Leaders

How You Will Benefit

• Understand the technical tools available for evaluation in the implementation of disposable technologies
• Apply risk management methodology for evaluating disposable technologies
• Analyze disposables and their operational use in varied clean room air classifications
• Understand disposable choices currently available by varying industry vendors for phase 0 manufacturing

Who Should Attend

Professionals from engineering, Process development, Manufacturing, Validation, Procurement

Communities of Practice (COPs)

This session is of particular interest to existing and future members of the following ISPE Communities of Practice (COPs):

API, Biotech, Disposables, Sterile Products Processing, and Sustainable Facilities