The company utilizes contract manufacturers approved by the FDA or other foreign regulatory authorities to produce its product candidates. These manufacturers are required to comply with current Good Manufacturing Practices (cGMPs) and other regulatory standards. However, the company has limited control over their manufacturing processes, quality control, and personnel. Failure to obtain or maintain regulatory approval for these manufacturers would necessitate identifying alternative facilities, resulting in significant costs and delays. Manufacturing complexities may lead to difficulties that could delay the supply of products for studies and trials. Third-party manufacturers may employ proprietary processes and could modify them without the company's consent, potentially causing product loss, failure, or increased costs. Changes to manufacturing processes during development may require regulatory amendments and additional studies, which could delay timelines. Expanding manufacturing capacity for clinical supplies, including key starting and intermediate materials, may be challenging or costly, and quality issues may arise during scale-up.
Kronos Bio Inc's Comment on Supply Chain
The company utilizes contract manufacturers approved by the FDA or other foreign regulatory authorities to produce its product candidates. These manufacturers are required to comply with current Good Manufacturing Practices (cGMPs) and other regulatory standards. However, the company has limited control over their manufacturing processes, quality control, and personnel. Failure to obtain or maintain regulatory approval for these manufacturers would necessitate identifying alternative facilities, resulting in significant costs and delays. Manufacturing complexities may lead to difficulties that could delay the supply of products for studies and trials. Third-party manufacturers may employ proprietary processes and could modify them without the company's consent, potentially causing product loss, failure, or increased costs. Changes to manufacturing processes during development may require regulatory amendments and additional studies, which could delay timelines. Expanding manufacturing capacity for clinical supplies, including key starting and intermediate materials, may be challenging or costly, and quality issues may arise during scale-up.
Sources:
Kronos Bio 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.
Updated on:
For your research, we’ve provided nine additional tables on Kronos Bio Inc ’s suppliers.
You can find them in the navigation menu under Suppliers.
To download the tables, please subscribe.
Intraday data delayed per exchange requirements. All quotes are in local exchange time. Intraday data delayed 15 minutes for Nasdaq, and other exchanges. Fundamental and financial data for Stocks, Sector, Industry, and Economic Indicators provided by CSIMarket.com
Disclaimer: Information provided by CSIMarket.com is for informational purposes only and does not constitute investment advice, recommendation, or solicitation to buy or sell any security.
