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PDA Journal of Pharmaceutical Science and Technology

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Case ReportCase Study

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

Ernie Jenness and Sue Walker
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 381-383; DOI: https://doi.org/10.5731/pdajpst.2014.00985
Ernie Jenness
Process Solutions, Mobius Product Manager, EMD Millipore Corporation, 80 Ashby Road, Bedford, MA 01730 USA
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Sue Walker
Process Solutions, Mobius Product Manager, EMD Millipore Corporation, 80 Ashby Road, Bedford, MA 01730 USA
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  • For correspondence: sue.walker@emdmillipore.com
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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.

  • Single-use technology
  • Final fill
  • Vaccine manufacturing
  • © PDA, Inc. 2014
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PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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Advantages of Single-Use Technology for Vaccine Fill-Finish Operations
Ernie Jenness, Sue Walker
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 381-383; DOI: 10.5731/pdajpst.2014.00985

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Advantages of Single-Use Technology for Vaccine Fill-Finish Operations
Ernie Jenness, Sue Walker
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 381-383; DOI: 10.5731/pdajpst.2014.00985
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  • Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
  • Risk-Based Approach for Analytical Comparability and Comparability Protocols
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