Presentation Roche Diagnostics
DAMAS – Data Acquisition, Management and Analysis System - an integrated Electronic Lab Notebook @ work
Name: Georg Pollinger
Company: Roche Diagnostics
Title: Business Process Owner DAMAS DSP non GMP (Data Acquisition Management and Analysis System)
Dipl. Ing. Biotechnology, University of Applied Sciences Weihenstephan
Since 2010 - involved in the development of DAMAS, currently Business Process Owner for DAMAS (Data Acquisition Management and Analysis Software) in Downstreaming Process Development non GMP at Roche Diagnostics, Penzberg
2008 - Downstreaming Process Development at Roche Diagnostics, Penzberg
2008 - Master Thesis, Molecular Acoustic for Formulation Development, Sandoz, Munich 2006/2007 Fermentation of bacteria to produce novel biopolymers at UNSW, Sydney, Australia 2006 Hybridoma Development at Roche Diagnostics, Penzberg
2004 - Formulation development for first generic Erythropoetin at Sandoz, Munich
2001 - Quality Control of Solid compounds at Hexal, Holzkirchen
The process development at biopharmaceutical companies is facing various challenges concerning the acquisition, management and analysis of complex data. The quality requirements are rising continuously as well as the complexity of experiments.
As part of a strategic initiative Roche developed a validated system called DAMAS that merges an electronic lab journal with material management/ substance preparation and sample management with linked equipment. DAMAS covers the complete experimental chain of process development from planning through experimentation, documentation and data evaluation in a fully electronic manner. This presentation focuses on the challenges and benefits of going paperless in the process development environment where finding the right balance between usability and flexibility is a top priority.
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