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Protein Analytical Technologies
3-4 March 2009
Barcelona, Spain
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Bringing Compliance and Science Together
Objectives
Biopharmaceutical processes and the specifics in the control of these processes are highly complex. A profound analysis of the quality of the drug substance, e.g. in the production of recombinant proteins, is of utmost importance – in many cases on a much higher level compared to the „classical“ pharmaceutical industry. In addition, the drug product alone may cause real challenges due to the restraints created by the nature of the protein.
Over the last years a huge variety of analytical methods ranging from physicochemical tests to biological assays have been established.
As the range of biopharmaceuticals is evolving, at the same time new tests have to be developed, validated, transferred, applied – and last but not least have to be accepted by regulatory authorities.
At this course, pros and cons of established and newly emerging assays will be discussed. Industry experts will share their in-depth knowledge and experiences. During workshops a focus will be set on validation issues.
This course will bring together representatives of the biopharmaceutical industry and regulatory authorities.
It has been designed to answer your individual questions concerning assays for the quality control of proteins.
Therefore, the number of participants is strictly limited.
We recommend early registration.
PROGRAMME:
- Why do we test? What must be analyzed?
- Spectroscopic Analysis
- Electrophoresis / Capillary Electrophpresis
- Liquid Chromatography
- Methods for antibody characterization
- Mass Spectrometry
- Validation of Protein Analytical Technologies
- FACS and Biacore Methods
- Method Development and Validation during Preclinical and Clinical Phases
- Case Study: Analytical tools in the analysis of biopharmaceuticals at Organon |
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