Issue link: https://www.e-digitaleditions.com/i/1535562
8 Pharmaceutical Technology ® | BioPharm International ® Trends in Manufacturing May 2025 PharmTech.com orator y information management systems for QC data collection can streamline data connection and analysis for drug product release. The deployment of process analytical technology and artificial intelli- gence could further optimize the end-to-end supply chain for cell therapies within the IDMO model. This full-stack, in-house integration is a key advan- tage of the IDMO approach, because it lends itself well to the kind of standardization the industry desperately needs for long-term success. It is more seamless than as- sembling systems that may not have been fit for purpose or designed to interface and work together smoothly. It also is a way of ensuring the accessibility of reliable data on where a specific batch is in the manufacturing process at all times—allowing cell therapy companies to focus on what is most meaningful for their patients while still offering the "white glove" service physicians and hospitals require for these complex products. True decentralization When people in this space discuss decentralized man- ufacturing, they typically mean something close to point-of-care, with miniaturized technology to fit in a hospital or a mobile unit nearby. The IDMO approach adopts some of the key advantages associated with de- centralization, while decreasing the relevance of others. Integrating all data systems requires cloud-based management, which is useful for securing data and means that servers do not need to be onsite. It also enables remote monitoring. There is less need to have someone on the shop f loor in a manufacturing clean- room when systems are fully closed and integrated. By comparison, decentralized manufacturing will have to balance some degree of remote oversight with extensive training protocols that empower hospital staff to perform manufacturing themselves. Today, hospitals do not have the capabilities, experience, or desire to be in the drug manufacturing business. Because so much of the manufacturing f lexibil- ity operates at the software level, with standardized hardware pieces at each location instead of different staff requiring new training, remote monitoring can also make technology transfer more f luid. That is highly relevant for an IDMO because it means smart factories can be built in multiple geographies and quickly scale to meet total patient demand once a therapeutic developer secures a new market approval. At the same time, much of the allure of decentral- ization has been the promise of reducing the com- plexity of logistics. Hospitals wouldn't have to man- age and track therapies using a different system for each manufacturer. The biggest advantage would be reducing vein-to-vein time, getting autologous therapies back to patients faster. But the IDMO can simplify this in different ways. For one, the scalability of smart factories means they will not be capacity constrained the same way the modern CGT manufacturing facility tends to be— or how a hospital could be if local demand outstrips the number of units they have on site. That lack of constraint helps with the predictability of the process, which has positive downstream benefits, as a hospital can more reliably allocate beds and resources when they know an infusion is going to happen for a patient on a specific date. That is going to be a big differentiator with the next wave of cell therapies, which are expected to branch out into autoimmune indications with much larger patient populations. The modular, local approach will mean an inconsistent but persistent need to add more manufacturing capacity, and many hospitals are already space constrained. No manufacturing approach beyond the IDMO is positioned to meet the need for tens or hundreds of thousands of doses per year, decentralized or centralized. The need for scale The entire CGT field needs to be able to scale capac- ity, and nowhere is that more important than for ear- ly-stage developers and young companies. The nature of the CGT space is that many of these companies are born from exciting ideas in academia. One downside is that few academic institutions have access to scal- able manufacturing platforms and developing com- mercial-scale processes. As a result, therapeutic developers that partner with academic institutions often get locked into pro- cesses and workf lows that are not scalable. While t he i mpac t may not t r u ly be felt u nt i l a t herapy moves into later stages of development, changes at those stages require multiple comparability studies that can stymie or even end a clinical program. In parallel, facilities need to be built or bought, staff needs to be trained, and bottlenecks have to be ad- dressed anew. CELL AND GENE THERAPIES The scalability of smart factories means they will not be capacity constrained the same way the modern CGT manufacturing facility tends to be.