Processo de produção
When we start our shift, the evening shift explain everything that’s happened so we are up to speed. As first operator, I am responsible for the schedule, so everyone on the shift knows which product they will be working on that night. On the night shift we spread out the competencies so that we are all flexible and can potentially work on any one of the products we produce, namely – a human coagulation factor VIII concentrate and human normal immunoglobulin solutions.
In fine fractionation, we take the intermediates we receive from basic fractionation and purify them into final products. Cryoprecipitate is the intermediate which we use to produce the human coagulation factor VIII concentrate, and fraction II is the intermediate which we use to produce human normal immunoglobulin solutions.
First we take our intermediates and put them in a solution of either water or water/ethanol, depending on the product. The separation of the proteins begins in the next steps with chromatography.
The process continues with pH-adjustments and cleaning processes. We wash the product, with either water or salt solutions. We have steps in the process, called filtration, where we use different kinds of filters depending on the size of the molecule we wish to capture. When we are approaching the end of the process, we have a step called ultrafiltration which is a variety of membrane filtration in which forces like pressure or concentration gradients lead to a separation through a semi-permeable membrane.
Working the night shift suits me well because I get to be with my children longer than most other people.
Virus inactivation is one of the most critical stages of our process. The plasma is tested for viruses throughout the process, from the point of donation through to the finished products. Even if there would theoretically be any viruses, they would be deactivated at the solvent detergent (SD) step during purification. During this critical step, the temperature and stirring speed are tightly controlled and monitored. The solution is stirred using a propeller-driven motor. The tank has a set temperature point which is the ideal temperature for both the desired product and the solvent detergent chemical. In the case of the human coagulation factor VIII concentrate, we stir the mixture for eight hours and ten minutes at 25–26ºC. The control system registers all the temperatures and confirms that the solution has been stirred for the correct amount of time. We also manually look in the tank every hour to check that it is still stirring. We print out a graph showing the temperature line confirming that the solution has remained within the prescribed temperature range.
We always have an end filtration into a sterile vessel that we deliver to the pharmaceutical department for filling, and in the case of the human coagulation factor VIII concentrate, freeze-drying.
In general, the fine fractionation steps for all products are similar. However, there are differences. In the case of one of our human normal immunoglobulin solutions, for example, we have two viral inactivation steps and a phase of sedimentation, during which the product must lie still for 24 hours. And in this case, instead of washing the product three times as with the human coagulation factor VIII concentrate, it is washed once, during which the bigger particles are captured.
Every step of Octapharma’s production process is interdependent. Without our donors, we wouldn’t have plasma. Without basic fractionation, we wouldn’t have intermediates. Without product documentation, we can’t ensure and prove to the authorities that our work is done the correct way. Without the pharmaceutical department, we can’t prepare the products to be ready for patients.
Some years ago, we had a Christmas party and there was a speaker who said we should be proud because when someone asks what we do, we can say we save lives every day. That was a turning point for me. What we do is much more than just work. We take pride in what we do because we know it has an impact on people’s lives. You have to be at your best all the time, because that’s what we promised the regulatory authorities and, of course, our patients. It’s very easy to go to work when you know you are helping people to have the life that most of us take for granted.
I love spending time with my family. Every third week I have a free week and that’s when I work on our house, which is right beside a forest and a lake in the countryside. It was built in 1800 – our aim is to return it to its former glory and give the house its soul back.
Processo de produção