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Article

Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response

1
Infectious Disease Research Institute, 1616 Eastlake Avenue E #400, Seattle, WA 98102, USA
2
Microfluidics Corp., 90 Glacier Drive #1000, Westwood, MA 02090, USA
3
Pall Corp., 20 Walkup Drive, Westborough, MA 01581, USA
4
Sartorius Stedim North America Inc., 565 Johnson Avenue, Bohemia, NY 11716, USA
5
Department of Global Health, University of Washington, Seattle, WA 98102, USA
*
Author to whom correspondence should be addressed.
Pharmaceuticals 2020, 13(8), 168; https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080168
Received: 8 July 2020 / Accepted: 24 July 2020 / Published: 28 July 2020
(This article belongs to the Special Issue COVID-19 in Pharmaceuticals)
Squalene emulsions are among the most widely employed vaccine adjuvant formulations. Among the demonstrated benefits of squalene emulsions is the ability to enable vaccine antigen dose sparing, an important consideration for pandemic response. In order to increase pandemic response capabilities, it is desirable to scale up adjuvant manufacturing processes. We describe innovative process enhancements that enabled the scale-up of bulk stable squalene emulsion (SE) manufacturing capacity from a 3000- to 5,000,000-dose batch size. Manufacture of concentrated bulk along with the accompanying viscosity change in the continuous phase resulted in a ≥25-fold process efficiency enhancement. Process streamlining and implementation of single-use biocontainers resulted in reduced space requirements, fewer unit operations, and minimization of cleaning requirements. Emulsion physicochemical characteristics were measured by dynamic light scattering, laser diffraction, and HPLC with charged aerosol detection. The newly developed full-scale process was demonstrated by producing two 5,000,000-dose batches of bulk concentrated SE. A scale-up of adjuvant manufacturing capacity through process innovation enables more efficient production capabilities for pandemic response. View Full-Text
Keywords: squalene emulsion; vaccine adjuvant; nanoemulsion; process scale-up; emulsion manufacturing; adjuvant manufacturing; pandemic response squalene emulsion; vaccine adjuvant; nanoemulsion; process scale-up; emulsion manufacturing; adjuvant manufacturing; pandemic response
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MDPI and ACS Style

Phan, T.; Devine, C.; Laursen, E.D.; Simpson, A.; Kahn, A.; Khandhar, A.P.; Mesite, S.; Besse, B.; Mabery, K.J.; Flanagan, E.I.; Fox, C.B. Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response. Pharmaceuticals 2020, 13, 168. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080168

AMA Style

Phan T, Devine C, Laursen ED, Simpson A, Kahn A, Khandhar AP, Mesite S, Besse B, Mabery KJ, Flanagan EI, Fox CB. Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response. Pharmaceuticals. 2020; 13(8):168. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080168

Chicago/Turabian Style

Phan, Tony, Christian Devine, Erik D. Laursen, Adrian Simpson, Aaron Kahn, Amit P. Khandhar, Steven Mesite, Brad Besse, Ken J. Mabery, Elizabeth I. Flanagan, and Christopher B. Fox 2020. "Squalene Emulsion Manufacturing Process Scale-Up for Enhanced Global Pandemic Response" Pharmaceuticals 13, no. 8: 168. https://0-doi-org.brum.beds.ac.uk/10.3390/ph13080168

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