Nowadays, biological medicines are mainly produced using single-use components rather than stainless-steel equipment. According to Jeroen van de Laar of Ardent Biopharma, production could become cheaper if single-use (SU) components, such as bags and bioreactors, were more comparable in terms of quality. However, due to a lack of information, switching to equivalent alternatives is difficult because it is unclear whether the entire bioprocess would still meet strict GMP requirements. Van de Laar is now contributing to the development of an international standard for SU components to address this information gap.
Van de Laar has worked in the biotech and pharmaceutical sector for more than 25 years, with expertise in process development, production, quality, regulation, and validation. He has worked as a freelancer since 2018, currently for Ardent Biopharma, a developer of a continuous production process for biosimilars. Over the years, he has seen the SU technology market mature significantly. “When I worked with it at Sanquin around 2010, new processes were mainly set up using SU components, while existing GMP processes continued to run on stainless steel. From 2018 onwards, I saw the cost of SU components decrease, supply increase, and compatibility between components improve. As a result, the benefits became increasingly significant.”
COVID
With the arrival of the COVID-19 pandemic in 2020, the situation changed abruptly. “I was working as a freelancer at Janssen on the production of a COVID-19 vaccine, where everything was produced using single-use (SU) technology. Suddenly, there was huge global demand for SU components, because they allowed new processes to be set up much faster, without the need for time-consuming validations. Deliveries were delayed, prices skyrocketed, and consequently, the costs of vaccines and other medicines threatened to rise sharply as well.”
Finding alternative suppliers proved difficult. “You didn’t know whether the alternative components met the same requirements as the original ones. In that case, you would need to revalidate the processes to continue meeting GMP requirements. Sometimes, even international negotiations through government ministries were necessary to obtain components and keep vaccine production running.”
ISO Standard
As a result of this experience, Van de Laar realized the need for greater interchangeability among SU components from different suppliers. Clear standards are required for this. He is now part of a NEN-ISO committee working on an international standard for a SU-component. “We started as a NEN group, but it soon became clear that this standard needed to be developed globally. It will therefore become an ISO standard.”
The committee is initially focusing on a relatively simple product: SU bags (single-use bag assemblies), which are used for, among other things, the storage of cells, intermediate products, and the preparation of buffers. Although they are relatively simple products, differences exist between suppliers, for example in airtightness, temperature and solvent resistance, and the release of substances from the material (extractables and leachables).
Organizations such as BPOG (BioPhorum Operations Group) and BPSA (BioProcess Systems Alliance, an American organization representing manufacturers and users of single-use technology) have already developed test methods and guidelines for this. The NEN-ISO committee is now bringing these together in an official standard. “Existing guidelines are valuable, but they are not sufficiently binding. An ISO standard has official and internationally recognized status, enabling regulators to enforce it more effectively.”
However, developing such a standard is a lengthy process involving multiple review and voting rounds. Van de Laar expects the standard to be ready in about two years.
Content of the standard
The standard describes, among other things, dimensions, material properties, production conditions (such as cleanroom classification), certifications of the manufacturing company, and performance under various conditions, such as exposure to acids, alkalis, solvents, or low temperatures. Information on extractables and leachables is also included. This standardized information enables customers to compare products more easily, switch suppliers, or select a backup supplier if certain products suddenly become unavailable or too expensive. It also allows producers to respond more quickly to customer needs.
Lower production costs
Van de Laar: “At Ardent Biopharma, and indeed across the pharmaceutical industry as a whole, we have an interest in producing biological medicines of the same quality at the lowest possible cost.”
Ardent develops biosimilars: biological medicines whose patents have expired. The company is working on a fully continuous production line for monoclonal antibodies, in which all components are single-use and quality control is largely automated. In this context, the cost per gram of antibody is a crucial factor. “Original biological medicines can cost as much as €100,000 per treatment,” says Van de Laar. “We can produce them much more cheaply. That will become even easier if we have better insight into the quality of single-use components from different suppliers.”
According to him, the new standard should facilitate the exchange of information between suppliers and users. “If everyone uses the same definitions and test methods, it becomes easier to compare products. This makes production processes more efficient and less expensive. Standardization is a normal step in the development of an industry. In the automotive industry, it has been common for years for car parts to meet established standards. Competition and interchangeability are ultimately good for the market and help make medicines better and more affordable.”
Jeroen van de Laar gave a keynote lecture at the Single-Use Event Leiden 2026