Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 22

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 22
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 is designed to manufacture fresh cell therapies. Our cell therapy product candidates are manufactured using our decentralized cell therapy manufacturing platform, which consists of an end-to-end xCellit® workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon®) and a proprietary quality control testing and release strategy. The platform offers the potential to deliver fresh, stem-like early memory cell therapy products near cancer treatment centers. This decentralized nature of our manufacturing process makes such processes more variable and difficult to reproduce than traditional small molecule chemical compounds or biologics. In order to manufacture our cell therapy product candidates, we must transport T-cells extracted from the patient’s blood following apheresis to our decentralized manufacturing units, engineer the cells ex vivo to express a specific biologic receptor for a specific target, and finally transport the fresh cell therapy product candidates to the treatment center for infusion into the patient.

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The manufacturing processes that we use to produce our cell therapy product candidates are complex, novel, have not been validated for commercial use, and are subject to multiple risks. Several factors could cause production interruptions, including equipment malfunctions, facility contamination, raw material shortages or contamination, natural disasters, disruption in utility services, human error, or disruptions in the operations of our suppliers. Moreover, unlike chemical pharmaceuticals, the physical and chemical properties of a such biologics therapy often cannot be fully characterized. As a result, assays of the finished product may not be sufficient to ensure that the product will perform in the intended manner. It is necessary to employ multiple steps to control our manufacturing process to assure that the product candidate is made strictly and consistently in compliance with the process. Problems with the manufacturing process, even minor deviations, could result in product defects or manufacturing failures that result in lot failures, product recalls, product liability claims, or insufficient inventory and supply.
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The decentralization of our manufacturing processes could place further burdens on management to manage such operations and maintain efficiencies and quality control. Our manufacturing processes may be susceptible to product loss or failure due to logistical issues associated with the collection of patients’ cells and the infusion of the patient with our cell therapy product candidates. Product loss or failure may also be caused by a number of factors, including manufacturing issues associated with the variability in patient material, interruptions in the manufacturing processes, contamination, equipment failure, assay failures, improper installation or operation of Lonza’s Cocoon® system, vendor or operator error, inconsistency in cell growth, and variability in product characteristics.
If