Fina Biosolutions has picked Scorpius BioManufacturing to produce an E.coli-expressed CRM197, which is used in conjugate vaccines.
Under the terms of the deal, of which financial details have not been disclosed, contract development manufacturing organization (CDMO) Scorpius will manufacture an E.coli-expressed CRM197 conjugate vaccine carrier protein for FinaBio.
CRM197 is a genetically detoxified diphtheria toxin, which has been manufactured in the same bacteria that creates the diphtheria toxin used for the diphtheria vaccine.
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“FinaBio is the first to make it as a soluble protein in the E coli cytoplasm, using our FinaXpress platform. Scientists at FinaBio developed a unique E. coli strain with an oxidative cytoplasm that grows well in a fermenter and used it to express CRM197 with high productivity. We brand our CRM197 as ‘EcoCR’” for E. coli expressed CRM197,” a spokesperson for FinaBio told BioProcess Insider.
According to both parties, the collaboration will include analytical method implementation and phase-appropriate validation, down and recovery process optimization, scale-up, and cGMP bulk drug substance production of CRM197.
There has not been a time limit outlined for this collaboration and those involved “hope for this to be a long-term partnership” in order to continually manufacture CRM197 to meet the vaccine market’s demand.
The financial details of this partnership have not been disclosed. However, the spokesperson said this manufacturing program has been “funding internally.” Furthermore, work will take place at FinaBio’s microbial building located in San Antonio, Texas, “which is well equipped for this type of project.”
Additionally, Scorpius is “on track” to double its number of employees from 2022 – 2023 due to a rapid phase of growth.
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