Research & Development
We first extract the FVIII from the cells and then remove all the cells by centrifugation and filtration. The FVIII is concentrated and purified by five different chromatography steps and two pathogen clearance steps, including virus inactivation by solvent detergent (SD) chemicals and DNA removal by nano-filtration, before formulation and polishing.
When we receive batches from cultivation, several steps have to be done by the purification group simultaneously. Luckily, our team helps one another and our great mix of competencies is used to approach all challenges. I have 30 years of experience working in pharmaceutical production but had, until 2014, only been working in “the last steps” of production. When packaging and visual inspection was moved to Germany in 2014, I joined biopharmaceutical production. I saw it as a great opportunity and challenge to move into recombinant production. It was especially interesting for me to learn about this new and innovative technology with a human cell line. While I do not have any academic background within biotechnology, luckily I work in a team which has a lot of this knowledge and experience. It feels great to work in an environment where everyone works together and contributes with their individual strengths.
There are new projects in the pipeline, and I look forward to learning new things. I enjoy being involved in an area that is always developing.
I arrive at work at 7am every weekday. I usually start my day by checking and calibrating all the instruments and equipment. Then I have to prepare different buffers, e.g. a buffer which we run through all the equipment to clean it, and a salt-buffer used to release cells from aggregation.
Recombinant production is a delicate and sensitive process. The cells must be carefully handled to avoid contamination and having to reject the batch. The cells are very sensitive to changes in temperature and pH and these parameters have to be monitored carefully. Recombinant production, compared with plasma fractionation, is on a much smaller scale, as we handle, at most, some hundreds of litres, whereas in fractionation they are working with several tons of plasma per day.
The process steps of purification are always the same since they are executed according to regulated and pre-defined standard operating procedures. It is rewarding when, time after time, we produce a product that fulfills all specifications and is approved.
I believe that Octapharma is a company that considers the long term aspects and puts the patients in focus. There are new projects in the pipeline, and I look forward to learning new things and I enjoy being involved in an area that is always developing. I am here to make sure patients receive quality-controlled products that really help them in everyday life.
Research & Development