The biotech industry is undergoing a revolution in traditional manufacturing practices. Biological medicine involves harnessing genetically engineered organisms to produce products such as insulin, vaccines, and antibiotics. In past decades, commercial launch of new biologics would require a significant capital investment in new, mostly custom, manufacturing buildings and processes. Companies were forced to contend with lengthy timelines for construction and regulatory approval of manufacturing operations. In that environment, biotech companies were forced to weigh the significant risk of a developmental phase failure against first-to-market benefits for a novel product, product launch requirements, and new technology acceptance. New technologies, such as chimeric antigen receptors and gene therapy, are radically different therapeutic approaches and have not been well established commercially, further increasing the complexity of commercial planning for early phase development products.

Additionally, a traditional commercial manufacturing facility involves engineered, ultra-clean facilities to eliminate the potential for contamination of the product. The equipment and piping are traditionally stainless steel and stationary, requiring heavy amounts of cleaning and sterilization as part of the production process. The operating cost of these facilities is significant due to utility requirements, equipment lifecycle management, and quality/environmental monitoring.

The risk profile of the traditional approach has motivated biotech companies to think differently. A new paradigm—that of completely closed, single-use manufacturing—has emerged. With a significantly shorter timeline, companies can now purchase empty shells of all process equipment and source ultra-pure plastic bags and tubing for each production run. After the production run is complete, all components are disposed of, eliminating the cleaning process entirely. These single-use components are connected without exposing any part of the process to the surrounding environment, decreasing the stringent facility requirements and the need for elaborate regulatory processes and machinery. This new model reduces lead time for equipment setup, allowing companies to defer capital expenditures longer into the development cycle of the candidate drug. The single-use model enables a high degree of design flexibility and customization for future medicinal therapies by maximizing the utilization of a single manufacturing space without cross-contamination and other regulatory concerns. This flexibility allows for product diversification, with lower costs and improved ROI and risk profile.

This new technology does have limitations. First, the scale of these processes is limiting, as higher-capacity single-use systems are still being developed. Second, the recurring cost of single-use systems significantly increases the operational cost of production. Single-use systems greatly increase pressure on sourcing supply chains to source all single-use components needed for production. Another major consideration is the environmental impact of large amounts of biohazardous plastic being disposed of in landfills after each production run. Currently, there is no fully-adopted solution to recycle these components.

Industry-wide, the effort to characterize and model this new operating platform is underway. Major pharmaceutical companies are weighing the benefits and limitations of single-use systems using classical production modeling techniques. As the single-use technology develops and costs retract, more and more medicines will be produced using single-use systems, enabling faster-to-market new medicines in the future.

Brian Richards is a San Francisco-based Global Executive MBA 2019 student. He is a project manager at Foresight Engineering & Consulting, specializing in bio-pharm project execution.