By Mukta Acharya, General Manager, Flexible and Rigid Strategic Containment Business, Bioprocess Division, Thermo Fisher Scientific
Single-use technology (SUT) has come a long way in the last 20 years. Early on, biopharma and biotech 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 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.
The urgent need for a vaccine to combat the current SARS-CoV-2 pandemic further strengthens the argument for implementing SUT at a larger scale. Ramping up production to the volumes required for global vaccine distribution would be considerably slower with traditional stainless steel, as 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.