The company utilizes contract manufacturers to produce clinical product candidates in accordance with cGMP standards for clinical trials and commercial distribution. These manufacturers are subject to FDA and other regulatory inspections, though the company does not oversee their compliance. Manufacturing challenges or regulatory non-compliance may result in increased costs, delays in clinical trials, regulatory approvals, or commercial supply, and could lead to product recalls. Additionally, the company licenses certain technologies, including phage display technologies related to bacterial cell expression and antibody products, from third parties. The use of these licensed technologies is governed by contractual terms and carries risks such as potential license termination, which may affect the company's operations and commercialization activities.
Xoma Royalty's Comment on Supply Chain
The company utilizes contract manufacturers to produce clinical product candidates in accordance with cGMP standards for clinical trials and commercial distribution. These manufacturers are subject to FDA and other regulatory inspections, though the company does not oversee their compliance. Manufacturing challenges or regulatory non-compliance may result in increased costs, delays in clinical trials, regulatory approvals, or commercial supply, and could lead to product recalls. Additionally, the company licenses certain technologies, including phage display technologies related to bacterial cell expression and antibody products, from third parties. The use of these licensed technologies is governed by contractual terms and carries risks such as potential license termination, which may affect the company's operations and commercialization activities.
Sources:
Xoma Royalty Corporation'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.
Updated on:
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