The company utilizes both contract manufacturers and in-house facilities to produce clinical cGMP bulk drug substances for tablet vaccine candidates. Since 2017, it has developed its own bulk vaccine manufacturing process and established a small cGMP bulk manufacturing facility at its corporate headquarters in California. In November 2021, the company expanded by subleasing an additional GMP manufacturing facility for in-house bulk production. Initially, vaccine tablet manufacturing, including labeling, packaging, storage, and distribution, was contracted to third-party manufacturers. In 2016, the company established drug product manufacturing capabilities at its California headquarters, which is licensed by the State of California Department of Public Health Food and Drug Branch. It also constructed a new GMP facility in California for tableting, coating, and packaging vaccine candidates. Both the company and its third-party manufacturers are subject to FDA and local authority inspections to ensure compliance with cGMP regulations. Non-compliance could result in legal or regulatory actions affecting product availability. The company has previously encountered challenges with production yields, quality control, and quality assurance, which could impact clinical trials and commercialization if unresolved.
Vaxart Inc's Comment on Supply Chain
The company utilizes both contract manufacturers and in-house facilities to produce clinical cGMP bulk drug substances for tablet vaccine candidates. Since 2017, it has developed its own bulk vaccine manufacturing process and established a small cGMP bulk manufacturing facility at its corporate headquarters in California. In November 2021, the company expanded by subleasing an additional GMP manufacturing facility for in-house bulk production. Initially, vaccine tablet manufacturing, including labeling, packaging, storage, and distribution, was contracted to third-party manufacturers. In 2016, the company established drug product manufacturing capabilities at its California headquarters, which is licensed by the State of California Department of Public Health Food and Drug Branch. It also constructed a new GMP facility in California for tableting, coating, and packaging vaccine candidates. Both the company and its third-party manufacturers are subject to FDA and local authority inspections to ensure compliance with cGMP regulations. Non-compliance could result in legal or regulatory actions affecting product availability. The company has previously encountered challenges with production yields, quality control, and quality assurance, which could impact clinical trials and commercialization if unresolved.
Sources:
Vaxart Inc 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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