The Future of Single Use Instruments in Biopharma

Components that are disposable and have been in advance are examples of single use instruments. These include bags, tubing, filters, and other connecting elements. They provide short turnaround times, low capital costs, and significantly lower validation costs and almost every process has at least one part that can benefit from the conveniences that they offer.

It is becoming increasingly obvious, as more manufacturers move towards using single-use equipment, what kinds of innovations and enhancements are essential to make possible a future based on single-use components. For innovation to continue to drive change, a collaboration between companies and manufacturers on four important developments.

Future of Single Use Instruments

The concept of biocompatibility centers on mitigating and reducing the impact that Single Use Instruments plastics have on the production stream. This entails selecting materials with a single application that will not interfere with the normal development of cell cultures, will keep proteins stable, and will minimize the number of substances that migrate from equipment and leach into the production process (extractable and leachable). Studies are also conducted by manufacturers of single-use components to identify substances in their equipment that have the potential in pharmaceutical products.

Having an Understanding of Biocompatibility

Although these studies provide useful information, the manufacturers have not standardized their datasets. Each one concentrates on the particles that make up just one of the components, rather than taking into account the whole assembly. In addition, there is a multitude of compounds, and manufacturers are unable to test each customer’s molecule due to the volume of compounds. In addition, no regulation states that manufacturers is require to keep their initial biocompatibility profiles with time. Working with manufacturers who can guarantee standard formulations for an extended time would be beneficial for users who wish to maintain product consistency across batches.

Finally, because it is impossible to eliminate all particles from any product, there are regulations in place to minimize the amounts of substances such as subvisible particulate loads. However, these regulations do not address visible particulates. The initial presence of these particulates is still a concern for applications such as protein-based drug production even though manufacturers of pharmaceuticals can remove them using a downstream filter. For this to improve, the manufacturers can implement a strategy of continuous improvement to provide users with a higher level of assurance.

Improving The Assurance of System Integrity for Single Use Instruments

The assurance that single use instruments will not leak is consider container closure integrity (CCI), and it is one of the most important aspects of single-use components. Visual inspections of products for flaws are the primary method that manufacturers use to combat CCI at the moment; however, these inspections do not catch every potential issue that could result in a leak or contamination.

Additional steps can to ensure CCI compliance by users as well as by manufacturers. During the fabrication process, for instance, manufacturers can test the pressure decay using air or other types of gas tracers. Users are also able to try CCI upon arrival if any damage occurred while the product was being shipped. Because neither of these approaches will be sufficient, both sides must carry out standardized testing to guarantee that CCI will be achieve.

Solutions for Measurement and Automation are Being Developed

There is a growing demand for scalable inline and in situ process sensors as there is an increase in the number of scientists who use equipment that is only used once across multiple operations. This requirement has already driven a significant portion of the development that has taken place, but some manufacturers are still producing bioreactors that only provide reusable sensors.

The prevalence of technology designed for a single application is driving increased demand for integrated sensors designed for single use that are capable of a wide variety of measurements. Facilitating access to these sensors will make it simpler for businesses across the sector to adopt technology with a single application.

Establishing a Global Supply Chain That Is Resilient

The field of single use instruments is still undergoing development, and to keep up with the changing demands of global biopharmaceutical production, suppliers need to set up a network that is capable of doing so. Manufacturers need to be able to guarantee that all single use instruments will be readily accessible to all operations located anywhere in the world. The majority of today’s manufacturers center their business operations on specific locations because those areas supply them with high-quality equipment. It will be easier to maintain timely and consistent production by increasing the number of manufacturing nodes as well as implementing risk management strategies related to raw materials. This will also help to avoid risks such as having a single site disrupt the entire supply chain.

The future of supply chains for products with a single use can make better with strategies such as:

• Specifications of the resin and controls on the process

• Design space for film extrusion and controls over the process

• Long-term agreements with suppliers

• Manufacturing that takes place across multiple locations

• These methods can assist manufacturers in regaining control over the production of components, regardless of whether the materials are internally or by a third party.

The future of single use instruments depends on some factors, including biocompatibility and integrity assurance, the availability of sensors, and a trustworthy supply chain. These four strategies will increase the adoption of single-use systems in bioprocesses, as well as the trust in them. The users and manufacturers of biopharmaceutical applications, such as cell and gene therapy and the production of antibody-drug conjugates, can work together to secure improvements to biopharmaceutical applications by continuing their respective advancements.

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