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

Affiliation
Lyophilization Technology, Inc. ,Warminster ,PA ,United States
Dutill, Timothy S.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Archer, Michelle C.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
McCollum, Joseph;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Press, Chris;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
McNeill, Lisa;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Hawkins, Linda;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Phan, Tony;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Laursen, Erik D.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Cabullos, Richard;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Bouchard, Lisa;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Castro, Regie J.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Lin, Mong-Wu;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Roco, Jeralyn;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Blois, Cecile;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Adeagbo, Babatunde A.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Guderian, Jeffrey A.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Gerhardt, Alana;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Beckmann, Anna Marie;
Affiliation
Lyophilization Technology, Inc. ,Warminster ,PA ,United States
Trappler, Edward H.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Kramer, Ryan M.;
Affiliation
Access to Advanced Health Institute (AAHI; Formerly Infectious Disease Research Institute) ,Seattle ,WA ,United States
Fox, Christopher B.

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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License Holder: Copyright © 2022 Dutill, Archer, McCollum, Press, McNeill, Hawkins, Phan, Laursen, Cabullos, Bouchard, Castro, Lin, Roco, Blois, Adeagbo, Guderian, Gerhardt, Beckmann, Trappler, Kramer and Fox.

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