Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 23

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 23
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 for any reason a patient’s starting material is lost, or if any cell therapy product candidate does not meet the preset specifications, the manufacturing process for that patient will need to be restarted, potentially including the re-collection of cells from the patient, and the resulting delay may adversely affect that patient’s outcome. Moreover, the patient’s starting material may lead to variable product quality or quantity which could result in an out of specification or insufficient product.
It may happen that failed product candidate manufacture may prevent a patient from receiving our cell therapy product candidates. If microbial, environmental or other contaminations are discovered in our cell therapy product candidates or in the third- party facilities in which our cell therapy product candidates are manufactured, delays can occur and such facilities can be closed. If such contaminations or other product quality issues are not discovered and if as a result thereof patients are exposed to a health risk, we may be held liable. Our insurance may not cover those cases, or the financial coverage may not be sufficient. 

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Because our cell therapy product candidates are manufactured specifically for each individual patient, vendors and operators will be required to maintain a chain of identity with respect to the patient’s cellular material as it moves from the patient through the manufacturing process, and back to the patient for infusion. Maintaining such a chain of identity is difficult and complex, and failure to do so could result in adverse patient outcomes, loss of product, or regulatory action including a clinical hold or other suspension or termination of our clinical trials or withdrawal of our cell therapy products from the market, if approved. 
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Further, as product candidates are developed through preclinical to late-stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as decentralized cell therapy manufacturing methods, are altered along the way to optimize processes and results. Such changes carry the risk that they will not achieve their intended objectives, and any of these changes could cause our cell therapy product candidates or our manufacturing process to perform differently and affect the results of planned clinical trials or other future clinical trials or otherwise necessitate the conduct of additional studies, which can be costly and time-consuming. We and our vendors may not successfully establish a robust decentralized production process, including quality release and monitoring process, that fulfills the requirements of the FDA, the EMA, the MHRA, the MHLW/PMDA and any comparable regulatory authority. There can be no assurance that Lonza’s Cocoon® system for our cell therapy product candidates is viable and can be effectively scaled or transferred