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

Timothy S. Dutill,Michelle C. Archer,Joseph McCollum,Chris Press, Lisa McNeill, Linda Hawkins,Tony Phan, Erik D. Laursen,Richard Cabullos, Lisa Bouchard, Regie J. Castro, Mong-Wu Lin, Jeralyn Roco, Cecile Blois,Babatunde A. Adeagbo,Jeffrey A. Guderian,Alana Gerhardt,Anna Marie Beckmann, Edward H. Trappler,Ryan M. Kramer,Christopher B. Fox

Frontiers in Drug Delivery(2022)

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摘要
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.
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关键词
subunit tuberculosis vaccine candidate,single-vial
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