Presentation Roche Diagnostics
Presenter´s biography
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
Abstract
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.
Company Introduction
A pioneer in healthcare
We have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.
The frontrunner in personalized healthcare
Roche was one of the first companies to bring targeted treatments to patients. With our combined strength in pharmaceuticals and diagnostics, we are better equipped than any other company to further drive personalised healthcare. Two-thirds of our Research and Development projects are being developed with companion diagnostics.
The world's largest biotech company
We are the world's number 1 in biotech with 17 biopharmaceuticals on the market. Over half of the compounds in our product pipeline are biopharmaceuticals, enabling us to deliver better-targeted therapies.
The global leader in cancer treatments
We have been at the forefront of cancer research and treatment for over 50 years, with medicines for breast, skin, colon, ovarian, lung and numerous other cancers.
The leading provider of in vitro diagnostics
We offer doctors profound information to guide treatments and to answer more