The Future of Single-Use Components in Biopharma

Single-use equipment refers to disposable, pre-sterilized components like bags, tubing, filters, and other connecting elements. They offer quick turnaround times, low capital costs, and significantly lower validation costs – and virtually all processes have at least one aspect that can benefit from their conveniences.

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As more manufacturers adopt single-use equipment, it’s becoming clearer what advancements and improvements are needed to enable a future based on single-use components. Companies and manufacturers need to work together on four critical developments to continue driving change.

Understanding and Reporting on Biocompatibility

Biocompatibility focuses on mitigating and minimizing the way that single-use plastics interact with the production stream. This means choosing single-use materials that will allow cell cultures to develop normally, maintain protein stability, and minimize substances that leach from equipment and migrate into the production process (extractables and leachables). Single-use component manufacturers also perform studies to identify substances in their equipment that could end up in a drug product.

While these studies are helpful, manufacturers have not harmonized their datasets. Each focuses on the particulates of one component – rather than taking into account the entire assembly. Additionally, there is a plethora of compounds and manufacturers are unable to test every customer’s molecule.

Additionally, there is no regulation that manufacturers must maintain their original biocompatibility profiles over time. For users to keep products consistent across batches, it would be helpful to work with manufacturers that can guarantee standard formulations in the long term.

Lastly, since it's not possible to remove all particles from any product, there are regulations on minimizing substances like subvisible particulate loads – but those regulations do not address visible particulates. Drug makers can remove particulates like these using a downstream filter, but their initial presence is still a concern for applications like protein-based drug production. To improve this, manufacturers can adopt a continuous-improvement approach to provide users with greater assurance.

Improving Integrity Assurance for Single-Use Systems

One critical factor for single-use components is container closure integrity (CCI), or assurance that single-use assemblies will not leak. Right now, manufacturers address CCI by visually inspecting their products for defects – but this alone can’t catch everything that might cause a leak or contamination.

Both users and manufacturers can take additional measures to ensure CCI. For example, manufacturers can test pressure decay using air or other gas tracers during fabrication. Users can also test CCI upon arrival in case any damage occurred during shipping. Neither of these strategies will be enough on their own, so it’s important that both parties implement standardized tests to ensure CCI.

Developing Measurement and Automation Solutions

As more and more scientists use single-use equipment across operations, there’s an increasing need for scalable inline and in situ process sensors. This need has driven much of the development already, but some manufacturers still produce bioreactors that only offer reusable sensors.

The ubiquity of single-use technology is continuing to generate demand for integrated single-use sensors that can perform a range of measurements. Improving access to these sensors will help ease the incorporation of single-use technology throughout the industry.

Forming a Resilient Global Supply Network

The single-use technology field is still evolving, and suppliers need to establish a network that can meet the expanding needs of global biopharmaceutical production. It’s critical that suppliers can assure that any single-use equipment will be available quickly to any operation around the world.

Today, most manufacturers base their operations around particular locations that provide high-quality equipment. Increasing the number of manufacturing nodes along with risk management strategies related to raw materials will help keep production timely and consistent, and avoid risks like a single site disrupting the entire supply chain.

The future of single-use supply chains can be improved with strategies like:

• Resin specifications and process controls
• Film-extrusion design space and process controls
• Long-term supply contracts
• Manufacturing with multiple sites

These methods can help manufacturers take control over component production whether they produce materials in-house or externally.

Conclusion

Biocompatibility and integrity assurance, sensor availability, and a reliable supply chain are critical to the future of single-use technologies. These four strategies will increase the adoption and trust of single-use systems in bioprocesses. By continuing their advancement, users and manufacturers can work together to secure improvements to biopharmaceutical applications like cell and gene therapy and antibody drug conjugate production.