What is an analytical development scientist? (That’s me!)
The development of a particular class or type of drug can span long periods of time and consist of collaborations amongst hundreds if not thousands of people. During this entire process it is critical to have lab-based assays (methods/protocols/tests) that can characterize the drug product in it’s entirety. Is it safe? Is it effective? Does it elicit the kind of cellular response that was expected? Did an adjustment in the manufacturing procedure change it’s structure? Can the drug be held in the fridge or does it need to be stored in a freezer? These kinds of questions are answered by the analytical department within a biotech company.
You can imagine that for every type of drug (antibody, gene therapy product, small molecule, antisense oligonucleotides, etc.) there is a long and thorough list of tests that need to be run to fully characterize it’s physical, chemical, and biological properties. And you can imagine that as the drug comes closer and closer to human trials, the level of accuracy, precision, and sensitivity of these tests needs to increase.
It is, therefore, the job of analytical development scientists to understand the need for this characterization, identify gaps in the the list of methods, constantly optimize the protocols for better performance, and test samples of the drug throughout the development process. Eventually some of these analytical methods are utilized by quality control departments to carefully evaluate and release batches of the drug for clinical use.
What I love about being an analytical scientist is that 1) you have to have a strong understanding of the physical, chemical, and biological properties of the drug in question, 2) you are required to work with a large variety of scientific instruments that readout different kinds of information, and 3) there is a heavy emphasis on data accuracy and precision.
In the coming weeks I will focus more on individual types of analytical characterization methods!
What can you learn from this? I hope this gives you more insight into the makings of a product in the biotech industry.
Any questions for me? Any other analytical scientists out there?
**In this particular graphic I depicted a viral gene therapy drug product and some of the analytical properties associated with this kind of therapeutic.