Success in Single-Use Supply Assurance for Biotech

Single-use technology (SUT) has come a long way in the last 20 years. Early on, the biopharma and biotech markets embraced it, primarily in process development and early-phase clinical trials; but in recent years, the industry has seen higher adoption of SUT in cGMP manufacturing due to the many benefits it offers, such as shorter turnover time as well as reduced capital investment in equipment. The flexibility of SUT also allows for a more fit-for-purpose product that meets the needs of each manufacturer’s unique process.

As vaccine development demand surged during the SARS-CoV-2 pandemic, the argument for implementing SUT at a larger scale strengthened. Ramping up production to the volumes required for global vaccine distribution would have been considerably slower with traditional methods, since the timeline for building a greenfield stainless steel site from scratch is anywhere from two to five years, not including time for validation. Conversely, building and equipping a fully validated single-use facility can be done in a fraction of the time and up-front capital investment.

Yet, the rapid growth of SUT is not without its own challenges and maintaining assurance of single-use supply is of major importance to biopharmaceutical drug and vaccine developers. That is why Thermo Fisher Scientific employs a combinatorial strategy that utilizes standardization, global capacity expansion, and quality harmonization processes to ensure manufacturers have consistent access to high-quality products.

With more manufacturers looking to adopt SUT in a cGMP environment, the demand for product availability has increased significantly. To continue successful SUT adoption while avoiding supply shortages in the future, two steps are critical. First, SUT suppliers must establish an integrated and robust supply chain that services manufacturers well into the future. And second, suppliers and manufacturers need to collaborate and develop forecasting mechanisms that enable proper resource and capacity planning. It is everyone’s responsibility to work together to prevent any interruptions in the supply network that could lead to delays in SUT production or, worse, to drug shortages.

To read this full article and learn a forward-thinking strategy to help secure your foundation of supply, unlock the value of standardization, and create a reliable infrastructure of single-use supply, click here.

Learn more about all the biotech solutions and resources from Thermo Fisher Scientific.