COVID-19 has further increased already soaring demand for single-use tech according to a GSK expert who says boosting supply is key.

Most biopharmaceuticals are made in stainless steel systems. But the past decade has seen interest in using disposable single-use systems increase. Initially the focus was in clinical supply.

However, as Weibing Ding, director of GSK Pharma in King of Prussia, Pennsylvania told BPI East virtual conference delegates, a growing number of companies are trialing single-use systems for commercial-scale production.

Image: iStock/Mano Davar

“Single-use technology is the factor in transitioning the biopharmaceutical industry from traditional facilities to flexible plants,” Ding said, adding “single-use technology is ubiquitous in all unit operations in commercial drug substance and drug product manufacturing. Over 95% of BOM [bill of materials] can be single-use systems, or have single use components.”

Supply constraints

But despite this potential, there are challenges involved in using single-use systems with – according to Ding – availability being the difficulty at present.

“By now we all know there are many, many benefits of using single-use technology. However, as expected, there are challenges. Technical quality and regulatory based challenges are being addresses fairly effectively,” he said.

“Supply constraint has become the top constraint for the industry. The main contributing factors to the supply constraints include short of certain materials; inaccurate demand forecasts; and the COVID-19 situation.

“We need to be very careful here that elongated supply constraints to not turn the tide of single use system implementation. As the old saying goes, forewarned is forearmed.”

Solutions

Aside from increased demand, another issue is the lack of standardization. According to Ding validation processes take longer than they need to because the systems are different for each project.

“The qualification and validation work that includes product comparability assessment typically takes months to complete. The current situation is that the assemblies are custom designed by end users and suppliers. They are not interchangeable.

“To help expedite the delivery of drug products, including COVID-19 related vaccines and mAb products, there is a need to harmonize the design so that single-use systems from different suppliers – while meeting user’s functional specifications – can be used interchangeably.

He added, “To achieve that we need a diligent cross industry collaboration.”

Unstoppable

Nevertheless, Ding predicted single-use technology has a bright future, explaining “standardization is progressing well. Second, new technologies such as such as sensors and films are being developed.

“Third emerging modalities such as cell and gene therapies, ADCs and COVID-19 vaccine adjuvants and mAbs are all increasing the use of single-use technology.

He added, “Therefore, provided we resolve the supply constraint situation, single-use technology is the future of biomanufacturing and it is unstoppable.”