NIBRT zooms in on single-use technology during its ‘Introduction to Biopharma for engineers’ training course.
To advise customers properly, you need to know how their process works, of course. So what are the critical points? Which changes play a role, etc.? This is especially important when you’re in a market where developments follow each other in quick succession, such as in the biopharmaceutical industry. That’s why, on 3 February, I joined colleagues from sister companies in the Indutrade Group at a training course at the National Institute for Bioprocessing Research & Training (NIBRT) in Dublin, Ireland.
Checking out the process steps
At NIBRT, I took part in the ‘Introduction to Biopharma for Engineers’ one-day training course. It was interesting to hear more about the history of the biopharmaceutical sector, to focus on the differences with traditional pharmacy and to really check out all the process steps. They paid detailed attention to ‘upstream and downstream processing', the control of ‘fill finish operations’ and single-use technology.
Research and training courses
NIBRT organises research and training courses for the bioprocessing industry all over the world. Their mission is to support this industrial sector by providing a unique learning experience in a practical environment that depicts the most modern industrial bioprocessing facility. They also conduct trendsetting research in collaboration with biopharmaceutical companies. Organon is one noteworthy example of this. Together with Organon they conducted research into glycosylation in CHO cell cultures in order to increase the understanding of and control over the cell culture process. To do this, they combined NIBRT’s academic materials with Organon’s production knowledge.
Complete picture
During the training course at NIBRT, we went through the complete biopharmaceutical process. It included process phases that I wouldn’t normally focus on, such as the cell line and fill-finish (the phase in which the product has the highest value and for which we also supply single-use assemblies). While working together with customers, I usually focus on a specific part of the process in which they want to use single-use. At NIBRT, I was able to run through all the process components – both the stainless steel systems and the single-use components – and examine everything close up. The complete picture, from start to finish. A huge number of disciplines are required to develop a medicine. It’s important that we as a supplier continue to explore all the links and not just the process steps in which single-use technology is deployed.
Not whether, but how
At NIBRT, it turned out that the question is no longer whether single-use process systems will be used in the biopharmaceutical sector, but how. Unlike classical pharmacy, the biopharmaceutical sector produces many medicines for specific illnesses. To do this, it must be possible to switch more often and more easily between different production processes. Single-use is then ideal. Examples include single-use mixing systems, single-use bags instead of stainless steel vats, solutions to upscale cell culture, single-use bioreactors and sampling and filtration systems.
Quality
According to NIBRT, single-use technology makes biopharmaceutical processes safer, greener, faster/more flexible and cheaper. And it can all be done with smaller systems, thus saving space. The training really helped me realise how complex and costly it is to develop medicines and bring them onto the market. And therefore how important the quality of the production system is. Minor deviations can influence the quality of the process and the medicine and in that way endanger the health of the patient.
Single-use technology is the solution for the production of biosimilars (biological medicines that are similar to the original whose patent has expired) that must be produced at low cost.
Integral part
There is no doubt that the biopharmaceutical sector can no longer survive without single-use solutions. It is therefore a good thing that single-use technology is a fully-fledged part of the NIBRT ‘Introduction to Biopharma for engineers’ training course.
Wendy Korver (Twitter @WendyKorver)