Single-use (SU) technologies can help drug makers scale production and reduce costs. However, the lack of standardization between such systems is a challenge for an industry moving toward digital manufacturing. In biopharma, disposable technologies are already well established and widely used, according to Valentin Jossen, PhD, senior scientist, USP development at CDMO Lonza.

“SU systems and their constituent technologies are now an integral part of many biopharmaceutical production processes in the biotech industry, including at Lonza, notes Jossen. “Overall, the adoption of single-use systems in the biopharmaceutical production has been driven by their ability to increase flexibility and scalability, reduce contamination risks, lower costs, improve process efficiency, and promote environmental sustainability.”

SU systems are used to make every type of medicine—mAbs, hormones, vaccines, cell and gene therapeutics, and ADCs. They are also used during each part of the lifecycle from R&D, preclinical, and clinical production to commercial-scale manufacturing.

“At Lonza Ibex in Visp [Switzerland], we use SU technology to manufacture products from early development—toxicological and first clinical trials—up to commercial manufacturing for our customers,” Jossen says.

He cites the reduced risk of contamination between product batches as a major advantage, explaining, “SU systems do not need to be sterilized or cleaned, no SIP or CIP equipment required. Therefore, the footprint of a SU facility is smaller compared to a classical facility with stainless steel systems, which reduces operating costs.’

Eliminating SIP and CIP—sterilization-in-place and clean-in-place—combined with a smaller facility can yield significant cost savings in terms of labor, time, and resources, according to Jossen.

Standardization challenges

Jossen and colleagues looked at evolving industry use of SU systems in a recently published study. Their key finding was that although disposable technologies have many potential advantages, there are some challenges.

“Compared to conventional systems, the degree of automation of SU systems is still lower. One of the reasons for this is the lack of standardization and the limited flexibility in changing the design of SU systems,” he says.

The lack of standardization reflects the dynamics of the technology supply market, continues Jossen.

Lonza uses single-use technology to manufacture products from early development—toxicological and first clinical trials—up to commercial manufacturing for its customers. [Lonza]
“Compared to traditional manufacturing technologies, the choice of SU technologies is smaller, even though the number of suppliers has increased over the last decades. There are currently 4–5 major manufacturers of SU systems on the market offering platform systems for the entire production process.

“This also highlights a disadvantage of SU technology. The lack of standardization of SU systems can lead to a dependency of CDMOs on certain suppliers. Therefore, it is important to have a risk mitigation strategy, for example, different suppliers for the same SU component/consumable and direct contracts with the SU manufacturers.

“This fact also became clear during the COVID pandemic, when we witnessed pandemic-related shortages of consumables for SU systems.”

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