Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 24

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 24
---
 to third party vendors and operators for commercialization. To date, the Cocoon® system has not been used to manufacture any approved and marketed therapies. We are also dependent on a third party for the end-to-end xCellit® workflow management and monitoring software and if there are any issues with this software, we may be unable to obtain regulatory approval for our product candidates.
​
Any failure to follow regulatory requirements or any delay, interruption or other issues that arise in the manufacture or storage of our cell therapy product candidates as a result of a failure of our facilities or the facilities and operations of third parties to comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercialize our cell therapy product candidates near cancer treatment centers. 
​
Cell therapy product candidates that have been produced and stored for later use may degrade, become contaminated or suffer other quality defects, which may cause the affected cell therapy product candidates to no longer be suitable for their intended use. Furthermore, if our vendors or operators fail to deliver the required commercial quantities or supply of our cell therapy product candidates on a timely basis and at reasonable costs, we would likely be unable to meet demand for our cell therapy product candidates, and we would lose potential revenues.
​
The manufacturing process and facilities used to produce our cell therapy product candidates are subject to FDA, the EMA the MHRA, the MHLW/PMDA and any comparable regulatory authority approval processes and compliance with applicable cGMPs and Good Distribution Practices, and we and our vendors and operators will need to meet all applicable regulatory authority requirements on an ongoing basis, including requirements pertaining to quality control, quality assurance, and the maintenance of records and documentation. The FDA, the EMA and comparable regulatory authority enforce these requirements through facility inspections. In the EU, the national competent authorities are responsible for manufacturing facility inspections, but the EMA plays a coordinating role in ensuring that standards are enforced consistently throughout the EU. Facilities using our decentralized manufacturing platforms, including Lonza’s Cocoon® system, must be approved by the FDA, national competent authorities in the EU or comparable regulatory authorities. Vendors and operators are also subject to continuing FDA, EMA and comparable regulatory authority compliance. Our own or third parties’ facilities where Lonza’s Cocoon® system is in use may be unable to comply with these regulatory requirements. Poor control of production processes can lead to the introduction of contaminants, or to inadvertent changes in the properties or stability of our decentralized manufactured cell therapy product candidates that may not be detect