PDA Aseptic Manufacturing of Biopharmaceuticals Conference

This session is dedicated to the upcoming new guideline Manufacture of sterile Medicinal Products. Additionally, there will be presentations about filtration (including PUPSIT), single use systems, isolators, clean room behavior like gowning, environmental monitoring, process simulation and validation.

The technological developments and the new regulations have a strong impact on the pharmaceutical manufacturing. In this conference we focus on the aseptic processing, especially fill finish operations of biopharmaceuticals.

Conference Discussions will include

A Regulatory update: What is new in the draft Annex 1? This has an impact on European manufacturer but also on the member countries of PIC/s.

The environment of aseptic manufacturing: What are most advanced technical solutions from barrier systems, contamination control, cross contamination avoidance, testing and unit operations

Fill-finish operations: Standard filling lines, robotic systems, qualification, process simulation and regulatory aspects

Pharmaceutical Product quality testing: The technologies on visual inspection and container integrity, the current regulatory trends will be highlighted.