Lyophilization process engineering and thermostability of ID93 + GLA-SE, a single-vial adjuvanted subunit tuberculosis vaccine candidate for use in clinical studies

Promising clinical efficacy results have generated considerable enthusiasm for the potential impact of adjuvant-containing subunit tuberculosis vaccines. The development of a thermostable tuberculosis vaccine formulation could have significant benefits on both the cost and feasibility of global vacc...

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Veröffentlicht in:Frontiers in Drug Delivery 2022-01, Vol.2
Hauptverfasser: Dutill, Timothy S., Archer, Michelle C., McCollum, Joseph, Press, Chris, McNeill, Lisa, Hawkins, Linda, Phan, Tony, Laursen, Erik D., Cabullos, Richard, Bouchard, Lisa, Castro, Regie J., Lin, Mong-Wu, Roco, Jeralyn, Blois, Cecile, Adeagbo, Babatunde A., Guderian, Jeffrey A., Gerhardt, Alana, Beckmann, Anna Marie, Trappler, Edward H., Kramer, Ryan M., Fox, Christopher B.
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Sprache:eng
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Zusammenfassung:Promising clinical efficacy results have generated considerable enthusiasm for the potential impact of adjuvant-containing subunit tuberculosis vaccines. The development of a thermostable tuberculosis vaccine formulation could have significant benefits on both the cost and feasibility of global vaccine distribution. The tuberculosis vaccine candidate ID93 + GLA-SE has reached Phase 2 clinical testing, demonstrating safety and immunogenicity as a two-vial point-of-care mixture. Earlier publications have detailed efforts to develop a lead candidate single-vial lyophilized thermostable ID93 + GLA-SE vaccine formulation. The present report describes the lyophilization process development and scale-up of the lead candidate thermostable ID93 + GLA-SE composition. The manufacture of three full-scale engineering batches was followed by one batch made and released under current Good Manufacturing Practices (cGMP). Up to 4.5 years of stability data were collected. The cGMP lyophilized ID93 + GLA-SE passed all manufacturing release test criteria and maintained stability for at least 3 months when stored at 37°C and up to 24 months when stored at 5°C. This work represents the first advancement of a thermostable adjuvant-containing subunit tuberculosis vaccine to clinical testing readiness.
ISSN:2674-0850
2674-0850
DOI:10.3389/fddev.2022.1043756