Rook has held diverse positions at different CDMO´s, big pharma companies, as well as start-up companies in his more than 20 years of experience in biologics development and manufacturing. He remembers the first time he started working with single use systems at DSM biologics: “We heard a strange noise in our single use bioreactor. It appeared that the propellors had fallen off the shaft because the epoxy resin was not good. Another time the material of the reactors influenced the growth of the cells negatively because of leachables and extractables. The systems and materials have been improved a lot through the years. Today, in many cases, single use technology is a better choice than stainless steel. However there is a tipping point in scaling up where it becomes more economical to choose stainless steel. It’s just a matter of doing calculus, but it also depends on the size of vessels available.”

Hybrid approach

In the new large scale manufacturing facility in Visp a hybrid approach has been chosen. For the production of smaller quantities of biologics, single use bioreactors (up to 1000 litres) and components will be used. Single use technology makes the production more flexible because the changeover between the production from one type of product to another is much faster. However single use bioreactors are not yet available in larger sizes like 5000 and 20.000 litres. For these larger quantities of biologics, stainless steel vessels will be used. Also using stainless steel is sometimes more economical.

Flexible

The way in which the factory in Visp is being built is another way of being flexible. Lonza developed a modular manufacturing concept called Ibex^®️. This means that it is not known in advance what will be produced in the different modules of the factory and so they are empty. The modules will be developed with the future customer demand or market need at the moment of project commencement. “It makes you very flexible in situations like a pandemic (COVID-19) where there’s a sudden need to produce large quantities of medicine.”

Standardization

Although there are clearly numerous benefits to implementing single use technology, there are still some challenges, such as equipment compatibility and lack of standardization, as Rook experienced. “Every producer manufactures their own single use components like bioreactors, sensors and connectors, which do not always fit to components of other producers. That makes it very complex and also logistically challenging, especially if you are a worldwide company like Lonza,” he says. “Standardization might help to reduce complexity and support safe and sustainable biologics manufacturing.”