Manufacturing SARS-CoV-2 Omicron spike protein in grams

ExcellGene to Manufacture SARS-CoV-2 Trimeric Omicron Spike Protein, Optimized for Subunit Vaccine, Diagnostic and Drug Development

CHO-based cGMP Process Allows for Gram Quantities of Omicron and Delta Spike Proteins

Press release

MONTHEY, Switzerland, December 15, 2021 — ExcellGene SA today announces a new initiative for the mass production of the SARS-CoV-2 trimeric Omicron spike protein in CHO (Chinese Hamster Ovary) cells, which will help vaccine producers, diagnostic testing companies, and drug developers with optimal and abundant spike-protein material. This follows a similar initiative ExcellGene previously launched to meet demand for the SARS-CoV-2 trimeric Delta spike protein.

Dr. Maria J. Wurm CEO, ExcellGene

“Due to the significant need for SARS-CoV-2 trimeric Omicron spike protein, we have initiated its production in CHO cells to make gram-scale quantities,” says Dr. Maria J. Wurm, CEO of ExcellGene. She added, “Because we apply a state of the art, GMP-ready, CHO-based manufacturing approach, there are no barriers to scaling up the production of Omicron, Delta, and other variant proteins to the kilogram scale. In fact, this approach allows for the rapid production of billions of doses of highly potent, stable, and cost-effective vaccines.”
ExcellGene is an industry leader in the production of complex recombinant proteins and high-yielding Chinese Hamster Ovary (CHO) cell-based manufacturing process solutions. For 20 years, the Company has achieved high-quality manufacturing of challenging molecules by way of its deep knowledge of process sciences, including recently producing various SARS-CoV-2 trimeric spike proteins. Large quantities of SARS-CoV-2 trimeric Omicron spike protein are needed for various applications, from making diagnostic assays to use as substrates for drug and vaccine development. Recently, ExcellGene’s discovered that modified trimeric-spike proteins produced in CHO cells closely resemble the actual spike proteins found in contagious SARS-CoV-2 variants and are highly immunogenic [1,2,3].
“In early 2020, during the initial outbreak of the SARS-CoV-2 epidemic,” said Dr. Florian M. Wurm, Chief Scientific Officer of ExcellGene, “we used the SARS-CoV-2 genome sequence to produce trimeric ‘Wuhan’ spike proteins by using mutations that lock the protein in the ‘pre-fusion’ form, and we produced gram quantities in CHO cells by May 2020.”

Dr. Florian M. Wurm CSO, ExcellGene

Since that time, experimental vaccines containing ExcellGene’s SARS-CoV-2 protein were found to be highly immunogenic in mice, rabbits, and horses (pre-publication released in November 2021). One of the vaccines was shown to be protective against SARS-CoV-2 in a hamster model (publication under review). Neutralizing antibodies elicited by the vaccine were shown to be long-lasting (>280 days in mice) and highly cross-reactive against Alpha and Beta pseudoviruses [2]. Subsequent work with Alpha, Beta, and Delta variants has resulted in highly immunogenic and long-lasting antibodies. ExcellGene’s cGMP manufacturing process is fully scalable and uses only chemically defined components. This approach generates high-quality and high-purity proteins in a stable formulation that do not require ultra-low temperature for long-term storage or transport. “We are excited about our role in helping to produce large quantities of the SARS-CoV-2 trimeric Omicron spike protein,” said Dr. Maria J. Wurm. “Our Company has already been successful with increasing the manufacturing capacity of the Delta spike protein, and offering exceptionally pure and stable preparations to meet increased demand. We expect to meet this challenge with the Omicron spike protein variant, too.”

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About ExcellGene SA

ExcellGene is a contract development and manufacturing organization (CDMO) dedicated to helping researchers and industry partners who work on vaccines, diagnostics and drug development, by making available high-quality recombinant proteins and high-yielding Chinese Hamster Ovary (CHO) cell-based manufacturing services. The Company, headquartered in Monthey, Switzerland, and its team of 55 located in 16 different countries, is celebrating 20 years of high-quality services in the development and manufacture of therapeutic and vaccine candidate biologics, from DNA to process.

Established in 2001 by Drs. Florian M. Wurm and Maria J. Wurm, as a spin-off from the Swiss Federal Institute of Technology (Lausanne, Switzerland), ExcellGene continues its core focus on innovation and exceptional attention to detail with challenging projects, such as rapid SARS-CoV-2 spike protein production. The Company has served hundreds of clients and pioneered many innovations in the use of recombinant animal cells in bioreactors, and has shared insights and know-how to advance the industry as a whole through well-known publications. ‘Expect Great Science’ is the staple principle underlying all aspects of ExcellGene’s product and customer services. See here for more information.

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