The most important steps in the production of the prion-reduced pooled plasma are the pooling and the virus inactivation. We pool 600–1,500 individual plasma donations in an 800-litre stainless steel vessel. From that, we produce an average of 3,600 bags, which is 780kg of plasma. Pooling plasma gives us a standardized product. Pooling levels out individual heterogeneity of single plasma donations and reduces the variability of plasma components, resulting in consistent product quality.
Here in Stockholm we produce the prion-reduced pooled plasma, which is named because of the use of affinity ligand gel (LG) chromatography in the prion reduction step. There are 27 of us working on the production of this product in Stockholm and we operate in three shifts – day, afternoon and night. Everyone who works on in the team has an impact on producing that batch. We currently run four batches a week, which is planned to increase to five.
Working on the production of the prion-reduced pooled plasma, we get to see the whole process from start to finish. Our process involves the pooling of individual donations; filtration; virus inactivation; purification; prion reduction; sterile filtration and aseptic filling. Our job is to preserve the proteins: to do so, we regulate the temperature and pH (acidity level). Throughout the process, the ingredients are stirred continually to ensure a homogeneous product. We do everything, from thawing the plasma, right through to the point when it is frozen and packaged as a final product, ready for patients.
The final product is used during major operations and for major blood loss. There are also long-term patients who need regular plasma exchange. Without our plasma donors, we don’t have any product, so the act of donation is one of the most important contributions for patients. Knowing that the raw material we use is from plasma donors makes me feel more motivated to take care of it, and find new ways of improving production efficiency.
We recently underwent a major change by switching from one large chromatography column to small, parallel columns. This is more efficient both for maintaining the columns and for the process operators. There was a lot of planning leading up to the scheduled annual summer shutdown. I helped out with the installation, running the tests, and assisting in the cleaning validation. The validation batches, the first three batches we made after the change, demonstrate that the new process fulfills the requirements and product specifications.
I like the variety of my job most. One day I can be assisting with packaging, the next day I might be packing a column and on another day I may be abroad, doing a factory acceptance test (FAT) for a new machine. It’s a great mix between administrative and practical assignments. I enjoy finding new ways to improve efficiency using the principles of lean production. In my spare time, I am studying for a degree in technical engineering.