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.

An increasing number of our API’s are prepared by processes within organic chemistry. This includes, but not limited to, synthesis of small molecules and solid phase peptide synthesis. Furthermore, a big part of our API’s, originated from recombinant processes, also includes production steps performed by organic chemistry. Within our synthetic API platform, we also have a purification team focused on purification and spray drying of synthetic peptides.

In all of our API pilot plants we have teams dedicated to implementation and validation of equipment as well as optimizations and finding the right solutions for the API production. This includes change requests, deviations, validation protocols, reports as well as both larger and smaller optimization projects and investments.

To expand our capacity and make the API process steps as efficient and robust as possible, we focus on digitalisation and automation of our pharmaceutical manufacturing facilities. We use modern technologies as DCS (Delta V, Sattline and 800xA) to assure that our processes are executed as intended in a highly regulated, Good Manufacturing Practice (GMP) environment.

Our skilled Automation Engineers and Process Digitalisation Specialists translate our production processes into recipes that control our specific process steps. We are always on the lookout for talent within engineering, digitalization and automation and hire globally as well as various seniority levels.

In CMC API QA, we collaborate closely with key stakeholders to ensure a high level of quality in our processes and products. We constantly improve how we work and ensure that we live up the expectations of our patients, as well as requirements from authorities. We believe that ensuring simplicity and avoiding overprocessing leads to higher compliance and quality. 

We are responsible for approving qualification of equipment and facilities and releasing of API products. We are physically present during GMP activities to observe the performance of our processes and to help solve issues in real time and we play a huge role in our development projects to expand our production capacities. And all this, while working in close collaboration with our colleagues from CMC API Pilots, with whom we solve challenges through strong teamwork.