Expert workshop on process validation for the manufacture of biotechnology-derived active substances

• Date:
  Tuesday, 9 April 2013, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

This workshop addresses key questions concerning specific evaluation / validation data, which are required to confirm the reproducibility and robustness of the manufacturing process of biotechnology-derived active substances and ultimately guarantee a product of consistent high quality at the time of evaluation of the marketing authorisation. The event brings together experts and provides useful reference for the future European Medicines Agency guideline on process validation for the manufacture of biotechnology-derived active substances.

Documents

Abstract - Expert workshop on process validation for the manufacture of biotechnology-derived active substances

Agenda - Final programme - Expert workshop on process validation for the manufacture of biotechnology-derived active substances

Reference Number: EMA/34741/2013

Presentation - General concepts on process validation (Kowid Ho)

Presentation - Traditional approach: Upstream process (Kowid Ho)

Presentation - Traditional validation: Upstream (Vijay Chiruvolu)

Presentation - Scale down models for cell culture (Christian Hakemeyer)

Presentation - Traditional approach: Downstream process (Kowid Ho)

Presentation - Traditional validation: Downstream (Marco Strohmeier)

Presentation - Traditional validation: Downstream (Norbert Hentschel)

Presentation - Enhanced approach (Kowid Ho)

Presentation - Process validation: Enhanced approach - continuous process verification (Brendan Hughes)

Presentation - Process validation: Enhanced approach scale down models (Frank Zettl)

Presentation - Closing remarks on the workshop on process validation (Kowid Ho)

Multimedia