| Download | - View final version: A CHO stable pool production platform for rapid clinical development of trimeric SARS‐CoV‐2 spike subunit vaccine antigens (PDF, 6.0 MiB)
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| DOI | Resolve DOI: https://doi.org/10.1002/bit.28387 |
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| Author | Search for: Joubert, Simon1ORCID identifier: https://orcid.org/0009-0007-0405-8946; Search for: Stuible, Matthew1ORCID identifier: https://orcid.org/0009-0002-4403-0677; Search for: Lord‐Dufour, Simon; Search for: Lamoureux, Linda1; Search for: Vaillancourt, François1; Search for: Perret, Sylvie1; Search for: Ouimet, Manon1; Search for: Pelletier, Alex1; Search for: Bisson, Louis1; Search for: Mahimkar, Rohan1; Search for: Pham, Phuong Lan1; Search for: L'Ecuyer-Coelho, Helene1; Search for: Roy, Marjolaine1; Search for: Voyer, Robert1; Search for: Baardsnes, Jason1; Search for: Sauvageau, Janelle1; Search for: St-Michael, Frank1; Search for: Robotham, Anna1; Search for: Kelly, John1; Search for: Acel, Andrea1; Search for: Schrag, Joseph D.1; Search for: El Bakkouri, Majida1; Search for: Durocher, Yves1ORCID identifier: https://orcid.org/0000-0002-2268-4111 |
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| Affiliation | - National Research Council of Canada. Human Health Therapeutics
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| Format | Text, Article |
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| Subject | CHO clones; CHO pools; product comparability; quality attributes; SARS‐CoV‐2 spike protei |
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| Abstract | Protein expression from stably transfected Chinese hamster ovary (CHO) clones is an established but time-consuming method for manufacturing therapeutic recombinant proteins. The use of faster, alternative approaches, such as non-clonal stable pools, has been restricted due to lower productivity and longstanding regulatory guidelines. Recently, the performance of stable pools has improved dramatically, making them a viable option for quickly producing drug substance for GLP-toxicology and early-phase clinical trials in scenarios such as pandemics that demand rapid production timelines. Compared to stable CHO clones which can take several months to generate and characterize, stable pool development can be completed in only a few weeks. Here, we compared the productivity and product quality of trimeric SARS-CoV-2 spike protein ectodomains produced from stable CHO pools or clones. Using a set of biophysical and biochemical assays we show that product quality is very similar and that CHO pools demonstrate sufficient productivity to generate vaccine candidates for early clinical trials. Based on these data, we propose that regulatory guidelines should be updated to permit production of early clinical trial material from CHO pools to enable more rapid and cost-effective clinical evaluation of potentially life-saving vaccines. |
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| Publication date | 2023-07 |
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| Licence | |
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| Language | English |
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| Peer reviewed | Yes |
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| Export citation | Export as RIS |
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| Report a correction | Report a correction (opens in a new tab) |
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| Record identifier | 9878ecec-3c5a-4407-a26b-7b719b074767 |
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| Record created | 2023-07-17 |
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| Record modified | 2023-07-17 |
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