Biotechnology | Pharmazceutical Analysis | Analysis and Quality Determination in Biotechnological Drug Production

In addition to their curative effects, conventional, chemically manufactured drugs often also generate negative side effects. Not so biopharmaceuticals, i.e. active substances, which are not produced chemically but with biological organisms through fermentation. They act very specifically in the body. Their mechanism of action resembles that of natural processes which reduces the risk of side effects.

Fermentation describes the (industrial) conversion of organic substances. This biotechnological production method in which biological materials are converted with the help of fungi and cell cultures is not only used by the medical and pharmaceutical sector. Using microorganisms for the fabrication of goods which are difficult or impossible to produce by purely chemical means is also increasingly being applied by the energy, food and raw material industry.

Fermentation thus plays an increasingly important role in modern biotechnology. Many products of our everyday life, e.g. beer, yogurt, cheese and ultra-light and very stable materials are being produced by means of fermentation processes.  

Valuable Substance – Complex Production

The cell cultures used for the production of biopharmaceuticals need different nutrients to grow and multiply, the concentration of which must be measured continuously. This makes the production of biopharmaceuticals very complex and expensive. Taking into account economic considerations, production thus must be as efficient as possible and fluctuations in yield and yield must be avoided.

Mutual parameter dependencies and fast chemical reactions in this biotechnological process require intensive monitoring. At the same time, the measurement technology used must not have any effects, such as impurities, on the cell cultures. Traditional process analytical technologies could not achieve this and so time consuming offline measurements and manual sampling methods were often used instead. Immediate  intervention and accurate control of the process was not possible.