Single-use equipment has become ubiquitous in the biopharmaceutical industry, but further development in four key areas is needed to continue progress in this field.
▲Figure 1. Single-use equipment can include presterilized, disposable bags, tubing, fittings, and connectors. Bioreactor volumes up to 2,000 L are also available for completely single-use cell culture processes.
The biopharmaceutical industry has employed single-use systems consisting of bags, tubing, filters, and other connecting elements (Figure 1) for more than 25 years. Virtually all processes have at least one aspect that can benefit from the convenience of disposable, presterilized components. Many industries have rapidly adopted single-use technologies because they offer quick turnaround times, low capital costs, and significantly lower validation costs.
New biopharmaceutical facilities are able to benefit from a single-use system upon start-up, thus avoiding the costly buildout of a fully stainless steel reusable plant. The adoption of single-use equipment and the prevalence of contract manufacturing organizations (CMOs) can reduce the timescales and up-front investment costs required to develop pharmaceuticals.
As single-use technologies become more commonplace, users are demanding advances and improvements in these technologies and their associated processing techniques. The BioPhorum Operations Group (BPOG) has published a set of explicit requests and roadmaps for advances in biopharmaceutical production, some of which provide feedback on single-use technologies.
Users and equipment manufacturers must work together to improve single-use systems as the industry shifts away from reusable equipment. This article addresses four areas where development is needed, and discusses how together biopharmaceutical companies and equipment manufacturers will be responsible for driving change. These four areas for potential development are:
- understanding and reporting of biocompatibility
- improving integrity assurance for single-use systems
- integrating single-use measurement and automation to support process analytical technology (PAT) efforts
- developing a resilient global supply network.
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