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.

Target Audience

This course is of interest to those who are involved in

• Quality Control 
• Quality Assurance 
• Regulatory Affairs 
• Research and Development

of proteins, processes and analytical assays in the biopharmaceutical industry.

Registration

To register for this course please see the Registration Options.