Recombinant Proteins - Biologics

During the recombinant synthesis of a protein or an antibody, questions come up, for example how pure is my product, is it the correct product, what are the contaminants, are there any errors in my product. In the worst case, the protein or antibody does not show the correct activity, why? A major question to be answered.

Proteins or metabolites identified as
potential biomarkers for a disease need verification and validation. A study needs to be designed and the analysis of samples collected from healthy and affected individuals has to be carried out. This process has many pitfalls, a reason why most of the studies did not result in any useable findings. Study design, controlled analysis of samples and statistical analysis of the information is essential for such a process. A clear definition of the aims and a comprehensive communication between all involved participants can make such a story a success.

During a
drug development process the changes in a protein pattern is observed. The questions rising here are: what are the proteins and how much do their abundance change. Qualitative and quantitative Proteomics will answer these questions and lead to further process in the drug development process.

The
drug candidate shows unexpected side effects in cellular or animal studies. The question here is, again, why. Chemical Proteomics will identify off-targets to explain the side effects. This study requires the collaboration of medical chemistry, pre-clinical pharmacology, cell biology, bioinformatics and analytical laboratory.

How to answer these questions will be illustrated on the adjunct pages.