Single use is coming up
PROCESS: How do you evaluate the maturity level of disposables in biotechnology?
Berg: The level of maturity is good enough to build complete facilities in single use technology. At NNE Pharmaplan, we have developed a concept called Bio on demand to meet the demand for smaller and more flexible biotech facilities. It is a flexible concept which covers a wide range of applications with a predictable time schedule and budget — from the first conceptual and planning steps up to production.
PROCESS: Will disposables replace stainless steel or has this topic just drawn attention by the corresponding suppliers? When is it profitable to use disposables generally?
Berg: I do not think that disposables will replace stainless steel solutions. We see more and more so called hybrid productions where disposables and stainless steel equipment are combined. But the trend towards smaller volumes and higher yields supports the increased use of disposable technology.
Advantages of disposables are lower investment costs, higher flexibility, faster scalability, technology transfer as well as a lower contamination risk. But we need also to compare these benefits with the limited volume. At present, disposables can only be used up to 2,000 l fermenters. There are discussions ongoing if a higher volume makes technically sense at all because the handling of single use bags at larger volumes is not practical.
Also it needs to be considered that disposables are used for cell culture processes but are not suitable for microbial processes even though there are developments for small scales. A further disadvantage is that facilities cannot be automated to the degree of classical stainless steel facilities. This results in more manual handling and a greater demand on well-trained staff with an increased risk of errors. It is challenging to find the right balance needed to secure the requested flexibility for the pharmaceutical manufacturer.
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