AUTHOR=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. TITLE=Lyophilization process engineering and thermostability of ID93 + GLA-SE, a single-vial adjuvanted subunit tuberculosis vaccine candidate for use in clinical studies JOURNAL=Frontiers in Drug Delivery VOLUME=2 YEAR=2022 URL=https://www.frontiersin.org/journals/drug-delivery/articles/10.3389/fddev.2022.1043756 DOI=10.3389/fddev.2022.1043756 ISSN=2674-0850 ABSTRACT=

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.