The project will cover proof-of-concept at small scale to drug substance and drug product manufacturing, including DSP process development, analytical toolkit assays set-up, quality control validation and CMC support, said the parties.
It will leverage Exothera’s services such as plasmid supply, full upstream and downstream process development, and manufacturing.
Vaccizone has developed and patented a method for delivering antigens and bioactive compounds to increase the stability and shelf life of complex biotherapeutics, like vaccines, monoclonal antibodies and cell and gene therapies.
The enhanced antigen/bioactive delivery method is based on Antigen Presenting Cells (APCs).
In its COVID-19 vaccine, ASC protein microparticles carry the tRBD domain of the SARS CoV 2 spike protein, forming a fusion with human ASC protein. The firm said the technology increases both the antigenicity of the COVID-19 antigen and enhances its stability at high temperatures, during freeze-thaw cycles, and in the presence of organic solvents.
Vaccines and immune therapies developed with ASC technology are thermostable and eliminate the need for cold-chain logistics for delivery and storage, according to the company.
Exothera is part of the Univercells Group, and Vaccizone said it is set to benefit from the services of the other companies under that umbrella, namely Quantoom Biosciences, Univercells Technologies, and Unizima:
Univercells will support Vaccizone with grant submissions while Unizima can offer deployment capabilities to set up manufacturing facilities in Turkey. Vaccizone and Quantoom Biosciences are also evaluating whether the ASC protein-based platform can be used for mRNA-based therapeutics formulation to improve thermostability and targeted delivery.
Vaccines for developing markets
In April, Exothera announced it had formed a partnership with ReiThera to develop what they called a large-scale, low cost per dose manufacturing process to deliver novel vaccines to low- and middle-income countries (LMICs).
Their collaborative effort was awarded a €3m (US$3.2m) grant by the Bill & Melinda Gates Foundation, with the idea the tie-up would deliver new low-cost vaccines based on ReiThera’s GRAd technology platform, against COVID-19 and HIV, mostly for LMICs in Africa.
The partners are looking to develop a scale-up manufacturing process for the production of ReiThera’s vaccine candidates based on its GRAd platform, including its COVID-19 vaccine candidate (GRAd-COV2).