Biopharmaceutical processes and the specifics in the control of these processes are highly complex. Compared to the “classic” chemical pharmaceutical products and processes, they are frequently on a much higher level – as, for instance, in the case of proteins. In addition, the drug product alone possibly poses 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, new tests have to be developed, validated, transferred, applied at the same time. And, last but not least, they have to be accepted by regulatory authorities.
In 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 in small groups, you will deepen your knowledge about special methods and their validation issues. The course has been designed to answer your individual questions concerning assays for the quality control of proteins. In addition, you will benefit from information on bioassays and current hot topics like host cell proteins. Therefore, the number of participants is strictly limited. We recommend early registration.