At Novo Nordisk we are working on the development of the first ever oral protein formulation treatment for type 2 diabetes. Our objective within R&D and in particular at the Oral Protein Formulation department, is to continue working on developing the next generation of oral protein treatments not only for type 2 diabetes, but also, for other chronic diseases. Formulation and analytical scientists and technicians play a fundamental role in the development of oral protein treatments.
Formulation Scientists & Technicians
Formulation employees play a critical role in developing and manufacturing the next generation of innovative oral products for pre-clinical and clinical trials, thereby paving the way towards the future manufacturing of the products.
Formulation technicians are responsible for the practical work performed in the lab, including the use of equipment for producing and analysing oral tablets. They are experts in the handling of equipment such as tablet presses, roller compactors, blending equipment, but also smaller equipment used to characterise tablets and granules.
are responsible for developing the final drug product and
manufacturing process for solid dosage forms for clinical and
pre-clinical trials. A formulation scientist leads the design and
development of formulations and processes, scaling up for
manufacturing of batches for clinical and pre-clinical trials,
preparation of product development reports and support for all
necessary quality documentation and documentation for regulatory submissions.
Formulation scientists typically have a background in biochemistry, pharmacy or other related areas. Experience within the formulation of protein and peptides and also oral protein formulation, tablet development or oral drug delivery are also characteristics of a formulation scientist. A minimum of 2 years of industrial experience or a PhD in a relevant field are often required.
Analytical Scientists & Technicians
Our analytical research employees are responsible for development and validation of analytical methods for tablet process development and batch release. They are also responsible for solid state characterisation including particle characterisation and stability studies.
Analytical technicians are experts in the use of chromatographic equipment such as HPLCs and UPLCs. An analytical technician conducts the analysis of the experimental results and together with the analytical scientists determines which methods are best for each specific experiment. An analytical technician needs to have experience with chromatographic equipment, be detail-oriented, data-driven and a good team player.
Analytical scientists are responsible for developing analytical methods such as spectroscopy-based methods, chromatographic methods or dissolution methods amongst others. Analytical scientists work in close collaboration with the formulation employees and are responsible for choosing the right analytical methods and provide them with the right data and analysis to support decision making.
An analytical scientist typically has a background in pharmacy, engineering or other related fields within analytical sciences. Our colleagues are experienced within pharmaceutical drug development process, and often this is combined with experience within peptide or oral tablet production.
OPF is part of Novo Nordisk’s R&D family. We develop oral products and their manufacturing processes in our pilot plants, as well as analytical methods. Our ambition is to develop break-through tablet products for chronic diseases based on orally available versions of pharmaceutical peptides and other molecules.
Marie Darting is a formulation scientist working at our R&D site in Måløv, just outside Copenhagen. Find out more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work can have on patients.