In CMC API Pilots, we bring research projects to life by applying the knowledge gained from the development area and generating new knowledge that is needed to produce the active pharmaceutical ingredients (API) for clinical trials. Even small improvements and optimisations done in our area have a substantial impact if a research project makes it ‘all the way’ to launch – this is reflected in our culture. Through a strong focus on digitalisation and automation, we use innovative technological solutions to continuously improve our processes.
In CMC API Pilots, we work smart to solve the challenges we face and speed up development timelines. Every day, we learn something new and grow together as a team. Our colleagues are highly skilled individuals with diverse backgrounds ranging from technicians to scientists and mechanical engineers. When we start new projects and processes, we work together to find solutions to the new challenges that we are faced with. All to ensure that we manufacture API for the clinical trials to run smoothly and contribute to our purpose of driving change for people living with serious chronic diseases.
We are looking for people with a background in natural sciences, particularly within biotechnology, pharmacy, chemistry, biology, and related subjects. To join our team, it is an advantage to have experience with pharmaceutical processes but that is not a requirement. We are looking for talent with a wide range of seniority to help us drive the development of our medicines for clinical trials. We welcome people who are curious, open-minded and have an innovative mindset. The kind of people who see opportunities where others see obstacles.
All our recombinant products start with a cell bank which is cultivated in appropriate conditions to maximise cell production of API. This is done by carefully monitoring the cells and making sure they receive all nutrients needed. One key part of the process is determining the right moment for harvesting (i.e. the API containing liquid surrounding the cells) and transferring the harvest for further processing in purification. Our teams of scientists and technicians are responsible for determining the right cell growth conditions and determining the best time for harvesting. This varies from project to project, making the work in cultivation quite dynamic.
In the next steps of the process there is a need to separate (purify) the API from all the other components present in the harvest (cell debris, nutrients, degradation products, water etc.). This is normally performed by applying filters and chromatographic technologies/processes, prior to the transfer of API to a stable form (e.g. liquid, frozen or dried). The API product is finally stored until used for production of drug product by our colleagues in Clinical Supply.