Drug development entails much more than just initial research to discover relevant targets and binders. For drug discovery to lead to an actual marketed product, drug candidates must undergo a lot of pre pre-clinical and clinical testing, accompanied by gradual progression in manufacturing process development.

These developments must be carried out in in accordance with specific regulatory requirements, designed to ensure that drugs that will be given to humans (or animals, in the case of veterinarian products) are safe and adequately effective. Biotech and pharma companies are therefore required to submit applications to the authorities if they wish to initiate a new clinical trial, market a new drug, or make changes to an already marketed drug. In the EU, the relevant authorities are the European Medicines Agency (EMA) and the national competent authorities of the individual EU member states, e.g. the Danish Medicines Agency (DKMA).
The scientific evaluations of the submitted applications are carried out by so so-called assessors.

I am a molecular biologist (PhD from Aarhus), and initially worked several years as researcher in academia before joining the DKMA as quality assessor of biological therapeutics, where I then worked for 3 years. My
specific role was to evaluate if given drugs are manufactured with sufficiently high and consistent quality (molecular properties, biological activity, purity). I have almost exclusively worked on recombinant proteins.
Based on my experiences as assessor, I will in this talk give an introduction to the regulatory aspects of drug development, and to how recombinant protein drugs are characterized, manufactured and controlled in
pharma. Furthermore, I will address job functions at the DKMA and related job functions in pharma.