While currently most production processes for biopharmaceuticals are assessed by laboriuos and time-consuming off-line analytics, a new process enables the monitoring of such processes in real-time. Sensors  combined with  mathematical models deliver information on the quality and quantity of the product, as well as on content and profile impurities. This allows an instant monitoring of processes, making processes safer, faster, cheaper and more efficient.

Have you ever thought about how drugs are manufactured? They are often produced by microorganisms which secret them into their environment: a soup of media, the target drug and waste that must be eliminated. In the pharmaceutical industry, people use chromatography columns to purify the medication. This process is used for more than a century for the separation of compounds. One may think that everything should be already known for such a well-established process. Yet, acib researchers found out recently that already the connecting tubes and valves affect the quality of the separation process and – in the end – product quality.

More efficiency, more quality, more process safety, less costs, less waste – these are the target specifications of each and every production process in chemical industry. It seems quite ambitious to meet all these requirements, but a new key word has entered the engineering world: process intensification!

Bioproducts for various applications such as pharmaceuticals, cosmetics, nutrients or industrial enzymes are manufactured with biotechnological methods; microorganisms or immortalized cell lines are the vehicles for production. Due to the long development times such products, especially in the area of pharmaceuticals, are often very expensive. The question is how can we make the production process of bioproducts faster, cheaper and fit for the future.

What lies behind the data shown on a LCD screen? What do the numbers express and moreover, can we trust them? Is the value displayed correct and can we deduct the right conclusion to set a responsive course of action?

Since the early days of bioprocess engineering shear associated protein aggregation was believed to be a real thread for proteins causing a decrease in production yield accompanied by higher costs. Although some research indicated that moderate shear rates do not aggregate proteins, the scientific consensus today is still not aligned. Recent results suggested that elongational forces, very similar to shear, can unfold proteins. Hence, there is a strong demand for a technical solution to describe extraordinary high shear rates and investigate their impact on protein aggregation, to answer this unsolved mystery in bioprocess engineering.

Among global problems, shortage of water resources is considered one of the grand challenges humankind is facing. With growing industries, water consumption and wastewater treatment becomes more problematic. As the large-scale production of biopharmaceuticals increases worldwide, this industry sector has to develop strategies to minimize the environmental footprint as well.

Most of the active components in drugs either are compounds obtained by chemical synthesis or biomolecules produced by microorganisms (often proteins), which are then called biopharmaceuticals. When we talk about biomolecule production it can be separated into two sections: the up- and downstream-process. The main focus of an upstream-process lies on the preparation of the host cells and their fermentation. After a successful production the target protein needs to be separated from impurities. Protein purification – the downstream process – is an important procedure used to produce biomolecules in a highly pure form for the use in human healthcare.

Co-author: Verena Beck

While for scaling up a production process the main goal is to keep the quality and quantity of a product stable, scaling-down is often used for troubleshooting and testing unit operations. At the microscale various process parameters such as temperatures, buffer additives or mixing conditions can be tested much faster and with lower material consumption compared to large scale. Researchers of acib investigated the most crucial parameters affecting the mixing behaviour at the microscale and how mixing of fluids in small scale can be compared to large vessels.

Virus like particles are important tools in the medical field for vaccination or drug delivery systems. They mimic the outside structure of a virus but cannot reproduce themselves anymore. The purification thereof is still a challenge, but some techniques are published already.