From Concept to Delivery: A Yeast-Expressed Recombinant Protein-Based COVID-19 Vaccine Technology Suitable for Global Access

Authors

Peter J Hotez
Rakesh Adhikari
Wen-Hsiang Chen
Yi-Lin Chen
Portia Gillespie
Nelufa Y Islam
Brian Keegan
Rakhi Tyagi Kundu
Jungsoon Lee
Zhuyun Liu
Jason T Kimata
Numan Oezguen
Jeroen Pollet
Cristina Poveda
Kay Razavi
Shannon E Ronca
Ulrich Strych
Syamala R Thimmiraju
Leroy Versteeg
Maria Jose Villar-Mondragon
Junfei Wei
Bin Zhan
Maria Elena Bottazzi

Publication Date

1-1-2023

Journal

Expert Review of Vaccines

DOI

10.1080/14760584.2023.2217917

PMID

37252854

Abstract

Introduction: The development of a yeast-expressed recombinant protein-based vaccine technology co-developed with LMIC vaccine producers and suitable as a COVID-19 vaccine for global access is described. The proof-of-concept for developing a SARS-CoV-2 spike protein receptor-binding domain (RBD) antigen as a yeast-derived recombinant protein vaccine technology is described.

Areas covered: Genetic Engineering: The strategy is presented for the design and genetic modification used during cloning and expression in the yeast system. Process and Assay Development: A summary is presented of how a scalable, reproducible, and robust production process for the recombinant protein COVID-19 vaccine antigen was developed. Formulation and Pre-clinical Strategy: We report on the pre-clinical and formulation strategy used for the proof-of-concept evaluation of the SARS-CoV-2 RBD vaccine antigen. Technology Transfer and Partnerships: The process used for the technology transfer and co-development with LMIC vaccine producers is described. Clinical Development and Delivery: The approach used by LMIC developers to establish the industrial process, clinical development, and deployment is described.

Expert opinion: Highlighted is an alternative model for developing new vaccines for emerging infectious diseases of pandemic importance starting with an academic institution directly transferring their technology to LMIC vaccine producers without the involvement of multinational pharma companies.

Keywords

Humans, Saccharomyces cerevisiae, COVID-19 Vaccines, COVID-19, SARS-CoV-2, Spike Glycoprotein, Coronavirus, Technology, Recombinant Proteins, Antibodies, Viral, Antibodies, Neutralizing, CORBEVAX, COVID-19, INDOVAC, SARS, SARS-CoV-2, microbial fermentation, recombinant protein, vaccine

Published Open-Access

yes

Recommended Citation

Hotez, Peter J; Adhikari, Rakesh; Chen, Wen-Hsiang; et al., "From Concept to Delivery: A Yeast-Expressed Recombinant Protein-Based COVID-19 Vaccine Technology Suitable for Global Access" (2023). Faculty and Staff Publications. 5678.
https://digitalcommons.library.tmc.edu/baylor_docs/5678