Earlier this year, Sebastian Bauer took up the position as Director CMC at CombiGene. The English Wikipedia lists 93 different meanings of the abbreviation CMC, in this case the three letters should be read as Chemisty, Manufacturing, and Control. More concretely, this means that Sebastian Bauer will work with the development of the processes and assays necessary for the manufacturing of CombiGene’s drug candidates. Ingeneious contacted Sebastian for an interview.
Can you tell us a little about your background?
“Absolutely. I am originally from Germany, specifically Karlsruhe in Baden-Württemberg. I did my PhD in analytical biochemistry at the University of Konstanz and my post-doc at Karolinska Institutet in Stockholm. During the last twenty years or so, I have held several senior positions in the pharmaceutical industry, often focusing on CMC issues. I most recently came from a large CDMO company, that is, a company that helps other companies in the pharmaceutical industry with various services in development and manufacturing.”
What attracted you to CombiGene?
”One of the most important things was the size of the company. I have previously worked at smaller companies, and I really enjoy that format. Smaller companies can be very agile, which means that some project elements can be carried out much faster than at larger companies, which suits my personality, I like to get things done.”
What is required for successful CMC work?
”Many things! But if I had to pick one thing, it would be that early in the project you have to have a fairly precise understanding of what is needed to get a product approved by the pharmaceutical authorities. If you do not have that understanding, there is a very great risk that you will choose the wrong path and that later in the project you will have to redo different elements, which means losses in both time and money. If, on the other hand, you have a clear picture of the goal right from the start, you can do things intelligently, which means that the work can be carried out very efficiently. If I were to add something to this, it would be that I would like to underline the great importance of the various assays that are produced to ensure that factors such as security and stability are handled in the absolute best way. The design of these analyses can be crucial.”
What are you mainly focusing on right now?
”To be honest, I’m still learning. CombiGene is a small company, but the scientific matter we deal with is at a high level. So far, I have had very good help from CombiGene’s Senior Program Director Alvar Grönberg who has introduced me to the COZY program, which has the greatest need of a CMC director right now. I have also spent a lot of time with CombiGene’s Chief Scientific Officer Karin Agerman, which has allowed me to quickly gain an understanding of critical CMC aspects in gene therapy projects. I have also had several contacts with CombiGene’s broad CDMO network. My first focus will now be the peptide project within the pain program COZY, which suits me very well as I have ten years of experience working with peptides.”
