Proteins & Adjuvants
Protein Manufacturing
Hawaii Biotech has the extensive experience and capabilities in our Honolulu facilities to produce high-quality purified proteins to support our internal vaccine development programs as well for research and development use by biotech and pharmaceutical and biotech companies.
Platform manufacturing is an important innovation that can speed the initial vaccine immunogen design and vaccine development process, and shorten the time needed for manufacturing and initial regulatory approval to begin Phase 1 testing. Platform technologies allow for application of standardized manufacturing process to multiple vaccines and create a collective database on their safety as well, which can shorten the preclinical development period. HBI has developed its proprietary Drosophila S2 cell platform in this manner.
Two mosquito-borne flavivirus vaccine candidates, DEN and WN, have been developed on this platform and advanced to clinical trials (NCT00707642, NCT00936429). These efforts have established the foundation for cell culture processes, purification processes, and analytical assays for release that are appropriate for cGMP manufacturing and, importantly, have met FDA regulatory requirements. These processes remain essentially the same as vaccine antigens are exchanged out (so called “plug and play”). This was demonstrated when the FDA was presented with a pre-IND briefing package in 2016 for a Zika vaccine candidate based on this platform and there were no concerns raised. More recently, these processes have been applied to the multivalent TBFV and CHIKV vaccine programs to streamline and expedite the development pathway for these innovative vaccine candidates.
Protein Manufacturing
Hawaii Biotech has the extensive experience and capabilities in our Honolulu facilities to produce high-quality purified proteins to support our internal vaccine development programs as well for research and development use by biotech and pharmaceutical and biotech companies.
Platform manufacturing is an important innovation that can speed the initial vaccine immunogen design and vaccine development process, and shorten the time needed for manufacturing and initial regulatory approval to begin Phase 1 testing. Platform technologies allow for application of standardized manufacturing process to multiple vaccines and create a collective database on their safety as well, which can shorten the preclinical development period. HBI has developed its proprietary Drosophila S2 cell platform in this manner.
Two mosquito-borne flavivirus vaccine candidates, DEN and WN, have been developed on this platform and advanced to clinical trials (NCT00707642, NCT00936429). These efforts have established the foundation for cell culture processes, purification processes, and analytical assays for release that are appropriate for cGMP manufacturing and, importantly, have met FDA regulatory requirements. These processes remain essentially the same as vaccine antigens are exchanged out (so called “plug and play”). This was demonstrated when the FDA was presented with a pre-IND briefing package in 2016 for a Zika vaccine candidate based on this platform and there were no concerns raised. More recently, these processes have been applied to the multivalent TBFV and CHIKV vaccine programs to streamline and expedite the development pathway for these innovative vaccine candidates.
Adjuvants
Hawaii Biotech has acquired rights to use a number of novel adjuvants, including its semi-synthetic saponin-based GPI-0100 which has been used in a variety of formulations and is suitable for parenteral and mucosal administration.
GPI-0100 has been utilized in several third-party clinical trials of prophylactic and therapeutic vaccine candidates. The company maintains an active Drug Master File on GPI-0100.
In addition to use in our own vaccine candidates, HBI makes its adjuvants available to third parties for license with specific product formulations.
Adjuvants
Hawaii Biotech has acquired rights to use a number of novel adjuvants, including its semi-synthetic saponin-based GPI-0100 which has been used in a variety of formulations and is suitable for parenteral and mucosal administration.
GPI-0100 has been utilized in several third-party clinical trials of prophylactic and therapeutic vaccine candidates. The company maintains an active Drug Master File on GPI-0100.
In addition to use in our own vaccine candidates, HBI makes its adjuvants available to third parties for license with specific product formulations.