How is all single-use not created equal?

Ray Baldwin, business development manager, Watson-Marlow Fluid Technology Solutions (WMFTS) explains how all single-use is not created equal and how you can tell the difference. 

Single-use systems are becoming more popular in bioprocessing to deliver sterility and protect product integrity. But not all single-use systems are fit for purpose, especially those which were not designed for the specific application for which they are being used. Choosing the right components is vital to ensure contamination is prevented and the system is not compromised, to protect both the manufacturer and patient, and to ensure Good Manufacturing Practice (GMP) requirements are adhered to.  

Benefits of single-use in biopharmaceutical manufacturing 

As the industry moves rapidly away from the era of blockbuster drugs, biopharma companies lean towards developing multiple medicines simultaneously to mitigate business risk and enhance chances of commercial success. Processing lines therefore require flexibility and the ability to pivot between different batches while still maintaining the highest levels of sterility and preventing contamination. This is particularly true for Contract Development Manufacturing Organisations (CDMOs) who offer specialised services to multiple pharma customers and therefore must move quickly and efficiently between batches. The growth of the CDMO market is expected to outpace pharma to 2028 with growing demand for their specialised services, but as competition increases, trust in contamination prevention is vital to their business success. 

Why aren’t some single-use systems up to scratch? 

Behind the times 

Many single-use systems were designed to meet 20-year-old specifications, but our understanding of optimal processing parameters, the materials available, and the regulations have significantly changed in this time. While updating the designs might seem an easy solution, any changes must be clearly documented and approved to ensure good change control governance is observed. The validation burden is of particular concern in this highly regulated industry, as falling foul of the regulators can cause delays and additional costs in the development timeline. In order to ease that pain, validation services provided by suppliers help to enable regulatory compliance and give manufacturers confidence in updating their designs to new specifications. 

Off label use 

Many single-use components offer potential benefits over and above those applications they were originally designed for. This, however, is a double-edged sword. Using components under different conditions than they were validated for, e.g. temperature, pressure and length of time, could lead to compromised quality. For fluid management in particular, maintaining consistent pressures and flow rates is key for consistent production quality and accurate volume control. Running processes for longer, at higher temperatures and pressures, could lead to tubing degrading and potential resulting fluctuations in pressure and flow rate, not to mention risks of compromised integrity and leakage. 

A matching set 

Peristaltic pumps are ideal for many biopharma applications as their high dispensing accuracies allow precise volumes to be added to bioreactors and final doses. The external motion of the pump can however result in external wear if tubing isn’t specifically designed for this purpose.  

Unlike wine, it doesn’t get better with age! 

Within the industry, contamination control is a key component of GMP compliance and a comprehensive contamination control strategy (CCS) is now a requirement of Annex 1. Processing often involves high-cost consumables and high value products, some of which are hazardous, so preventing leakage is also necessary to minimise risk and production costs. Designing systems to fully maintain their integrity throughout the system lifetime is therefore a priority. 

The chemicals used in biopharma processing can be corrosive, like sodium hydroxide, and over time exposure to these can result in damage to single-use components. Multiple properties affect the durability of a tube, including the material, its resistance to different chemicals, and the thickness. Choice of tubing will therefore determine whether it survives the cycle. This does present an opportunity for single-use. Changing fluid path components between batches allows the line to be optimised for that specific process, without limiting your production capabilities. The length of exposure can also impact degradation, so limiting stationary time with constant flow can help to minimise this. 

Preparing for the future 

It is impossible to know what the requirements of future processing systems will be. This fast-paced industry continues to innovate and develop novel treatment modalities and development methodologies that could completely alter the face of biopharma in the future. As we’ve seen with the rise of biologic therapies, the demands of these may require completely new processing systems. These advances are accompanied by increased regulatory demands to protect quality and patient safety, all of which combine to make future-proofing a processing line seem impossible. 

Single-use systems can be easily updated with new components to meet new requirements, making them a good choice for both present and future requirements. However, supply of these components should also be considered. With recent supply chain disruptions still fresh in the industry’s mind, working with a global partner that offers a reliable supply chain will help to minimise the impact of future industry supply issues. 

So, how should you plan your single-use system? 

Taking all of these factors on board can seem daunting, but the upfront effort will pay off with reliable, effective and efficient processing systems that deliver high quality products. Start by understanding the needs of your system and the end-goal, and bioprocess specialists will design a system that delivers long-term savings without being swayed by the promise of cheaper solutions in the short term.