Advantages of Single-Use Technology for Vaccine Fill-Finish Operations

Abstract

The biopharmaceutical industry continues to face enormous pressure to accelerate time to market, improve productivity and efficiency, and reduce costs. Vaccine manufacturers face additional challenges, including small batch sizes, varied product portfolios, pandemic outbreaks that require rapid responses and highly potent ingredients that place large demands on cleaning processes. Given these pressures, single-use fill-finish assemblies can represent an attractive option for vaccine manufacturing facilities. This article describes the implementation of a single-use fill-finish system at a large vaccine manufacturer. The new assembly enabled flexibility while reducing set-up time, capital investment, cross-contamination risk, and cleaning requirements.

LAY ABSTRACT: Overall the biopharmaceutical industry is constantly being challenged to bring new products more quickly and efficiently to market while keeping costs as low as possible. One specific segment of this industry is the companies that manufacture vaccines. Vaccines present unique challenges because they tend to be made in smaller amounts for a larger number of individual products. The products can also be very potent, which can require special handling methods. Another challenge is the potential outbreak of a disease that may affect a large area or a large part of the population and would require immediate action. Single-use assemblies for filling the product into its final container are an attractive option for vaccine manufacturing facilities. This article describes the implementation of a single-use filling system at a large vaccine manufacturer. The new assembly was flexible enough to meet the demands of the manufacturer while allowing quick and efficient implementation with low upfront investment.