The company relies on single-source suppliers for its product candidates, which presents risks related to supply quantity, cost, and quality. In May 2023, an issue with the vial stopper used by the vendor manufacturing DT-216P1 caused a short delay in product supply for a Phase 1 clinical trial. There is only one supplier for an excipient component of DT-216P2, and establishing additional sources may be difficult or impossible on acceptable terms. All contract manufacturers and entities involved in therapeutic preparation must comply with current Good Manufacturing Practice (cGMP) regulations enforced by the FDA and comparable foreign authorities. The company depends entirely on contract manufacturers for compliance with these regulations and is subject to potential unannounced inspections. Noncompliance could result in sanctions including shutdowns, fines, or recalls.
Design Therapeutics Inc's Comment on Supply Chain
The company relies on single-source suppliers for its product candidates, which presents risks related to supply quantity, cost, and quality. In May 2023, an issue with the vial stopper used by the vendor manufacturing DT-216P1 caused a short delay in product supply for a Phase 1 clinical trial. There is only one supplier for an excipient component of DT-216P2, and establishing additional sources may be difficult or impossible on acceptable terms. All contract manufacturers and entities involved in therapeutic preparation must comply with current Good Manufacturing Practice (cGMP) regulations enforced by the FDA and comparable foreign authorities. The company depends entirely on contract manufacturers for compliance with these regulations and is subject to potential unannounced inspections. Noncompliance could result in sanctions including shutdowns, fines, or recalls.
Sources:
Design Therapeutics 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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