Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional

By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1

Hosting Cell 2025 in London last month was one of the most energizing experiences of my career. As host, I had the privilege of guiding conversations with leaders who are shaping the future of cell and gene therapy. Throughout Cell 2025 and similarly at last month’s Advanced Therapies USA in Philadelphia, I expected to hear about all the usual topics, including process intensification, automation, regulatory readiness, novel modalities, and next-generation analytics. And I certainly did. But what surprised me was how often the discussions referred to one core theme that is becoming impossible to ignore throughout the sector, which is the need for platformization in CGT manufacturing.

I’ve moderated countless technical discussions over the years, and digital transformation has been a recurring topic, but things feel fundamentally different now. At both events, leaders weren’t talking about digital tools in isolation; they were talking about building resilient, connected ecosystems. They were talking about manufacturing execution system (MES), enterprise resource planning (ERP), and laboratory information management system (LIMS) not as independent systems but as interconnected pillars that must function as a unified backbone. They were talking about global connectivity and the operational consequences when those systems are fragmented. Platformization emerged not as a buzzword but as the key differentiator that will determine who successfully scales and globalizes cell and gene therapy operations in the decade ahead.

Overcoming the Disconnect of Disparate CGT Operating Systems

Indeed, platformization isn’t simply about implementing technology. It’s about designing an operational architecture capable of supporting the scientific, regulatory, and commercial realities of CGT. Many of today’s companies operate with an uncomfortable level of digital fragility. Their manufacturing systems, data repositories, quality workflows, and supply chain tools exist as isolated islands. This disconnect may be manageable for an early-stage program or a single-site manufacturing model, but it becomes deeply problematic once a therapy approaches Phase 2, expands to multiple programs, or prepares for global commercialization.

Manufacturing leaders at both events repeatedly emphasized that CGT companies now face a level of complexity that traditional biopharma systems were never designed for. They are managing donor-specific materials, multi-step autologous workflows, intricate chain on identity and chain of custody requirements, and quality systems that must capture and reconcile thousands of data points across multiple partners. At the same time, they are scaling into multi-site manufacturing footprints, often blending internal facilities with external CDMOs. And they are preparing for regulatory submissions that require data continuity, process control, and real-time visibility across every site in the network. Operating these programs on disconnected, legacy systems is becoming untenable.

Platformization is described not as standardizing on a single vendor but as creating a universal, interoperable digital foundation. In practice, this means building a harmonized data model that allows every system, MES, ERP, LIMS, scheduling tools, analytical databases, and supply chain systems to interpret, exchange, and contextualize information without human intervention. It means standardizing workflows for batch execution, QC testing, raw material qualification, deviation management, and lot release so that every site, whether internal or external, operates consistently. And it means modernizing the digital infrastructure itself, shifting toward cloud-native, API-forward systems that can integrate seamlessly with the next generation of manufacturing systems and automated analytics tools.

MES + ERP + LIMS = CGT Manufacturing Platformization

Some of the conversations at both events revolved around why MES, ERP, and LIMS have become so important in CGT manufacturing. MES platforms were described as the operational command center that drives process adherence and ensures chain of identity integrity, orchestrates in-process data capture and creates the digital memory needed for continuous process verification. As companies adopt more automated and closed-system manufacturing equipment, MES becomes the integrator connecting bioreactors, monitoring systems, analytics platforms, and sensor-driven workflows. ERP systems, in contrast, sit at the heart of the supply chain. They track raw material procurement, manage inventory, coordinate global scheduling and distribution, etc. In CGT, where variability in raw materials can derail an entire program, this level of control is essential. Meanwhile, LIMS platforms govern the quality ecosystem, allowing companies to manage sample workflows, coordinate QC testing, capture audit trails, and ensure that assay data feeds directly into release decisions.

What resonated repeatedly throughout the events was that none of these systems can function at their highest potential in isolation. MES without ERP leads to gaps in traceability. ERP without MES hinders batch visibility. LIMS that isn’t fully integrated introduces delays, inconsistencies, and manual transcription risks. Platformization ensures that each system acts not as a standalone tool but as a contributing part of a seamless operational whole.

Platformization as a Leadership Choice

Perhaps most importantly, I learned that platformization is not a technology project; it is a leadership decision. When a company chooses platformization, it is choosing to future-proof its manufacturing, quality, and supply chain operations. It is choosing to build systems that support expansion rather than restrict it. It is choosing to adopt a digital mindset that views data as a strategic asset rather than a series of isolated records.

Companies that embrace the platformization approach early will be far better positioned to handle global growth, diversify their manufacturing models, and meet increasingly complex regulatory expectations. As such, they may also achieve faster tech transfers, more predictable product release cycles, stronger partnerships with CDMOs, and improved resilience during scale-up and commercialization.