Cell and gene therapies have moved from experimental promise to clinical reality with remarkable speed. Scientific platforms have matured, regulatory pathways have adapted, and investment has accelerated programs targeting diseases once considered untreatable. Amidst this transformative innovation, the operational and digital infrastructure necessary for safe, repeatable, and scalable manufacturing has often lagged, compromising patient safety, regulatory requirements, and organizational efficiency.
In more than two decades working in regulated enterprise technology, and now leading global product strategy for SAP’s Cell and Gene Therapy Orchestration platform, I have seen early-stage organizations invest heavily in clinical advancement while postponing decisions about digital backbone systems. This approach may seem practical when patient volumes are low and teams are small, but it often causes vulnerabilities at critical handoffs where manufacturing tolerates minimal error.
Unlike traditional pharmaceutical production, autologous cell and gene therapy operations are patient-specific, tightly scheduled, and operationally interdependent. Each manufacturing run corresponds to a single identified patient. Each transition—collection, cryogenic transport, receipt, processing, quality review, and delivery—must align without interruption. When coordination relies on spreadsheets, email chains, and partially connected systems, risk accumulates quietly until growth exposes it.
Operational Reality in Early-Stage CGT Organizations
In many young CGT companies, laboratory environments are structured, disciplined, and carefully governed. Conversely, the operational processes connecting collection centers, manufacturing facilities, logistics providers, and quality teams often evolve more organically. Without an integrated digital system, label templates may be updated manually, shipment visibility and release documentation may reside in different platforms, and quality review requires reconciling information across multiple repositories before a batch can move forward.
This disproportion shows a prioritization of early capital toward clinical progress often at the expense of infrastructure. But CGT operations do not scale incrementally: processes that suffice for three patients may fail at twelve, when complexity overwhelms the mechanisms supervising manual workflows. As patient volumes and the number of partners increase, the frequency of handoffs rises and synchronized information becomes essential. In the absence of a structured digital backbone, accountability becomes diffused while traceability shifts from a preventive to a reactive function.
Why Operational Gaps Carry Elevated Risk in CGT
Although operational gaps exist in every manufacturing environment, the personalized nature of CGT amplifies risk. Unlike traditional pharmaceutical production, where batches are interchangeable and replacement inventory can mitigate disruption, autologous CGT provides no such buffer. Because each lot represents one patient, errors such as mislabeling or custody breaches have direct consequences for individual therapies.
In CGT, data volumes increase rapidly, with early phases generating thousands of records spanning collection, manufacturing, and logistics. This is complicated by regulatory agencies that expect demonstrable control over chain of identity, chain of custody, and data integrity from early development. As programs scale, the high cost structure associated with per-patient expense, critical timelines, and geographic complexity further compound systemic risk exposure.
Regulatory Scrutiny and Inspection Readiness
Digitalization is often framed internally as an efficiency initiative. However, from a regulatory standpoint, a digital infrastructure is foundational to demonstrating traceability, contemporaneous documentation, and auditability from the earliest stages of development.
Inspection discussions frequently center on who performed each step, when it occurred, how identity was verified, and how decisions were reviewed and approved. Paper-based and fragmented systems erode confidence, irrespective of scientific merit.
Operational, technical, and data-integrity controls that historically matured closer to commercialization increasingly draw attention as early as Phase 1-2 programs. At these stages, regulators are evaluating both therapeutic potential and whether the operating model can consistently ensure patient safety.
What Digital Orchestration Actually Delivers
Effective orchestration platforms provide guided workflows with e-signatures, dual patient identifier verification, scan-to-verify custody transfers, automated deviation flagging, and real-time integration with third-party logistics providers. These features support proactive detection of shipment delays that can lead to temperature excursions in CGT therapies, and redirect quality efforts toward managing exceptions instead of manual reconciliation.
Orchestration establishes a single source of truth across collection, manufacturing, logistics, and quality functions. When implemented deliberately, data is captured contemporaneously, structured for audit, and accessible across stakeholders without parallel tracking in spreadsheets.
Impact of Digital Orchestration on Real CGT Operations
While organizations may hesitate to pursue early digitalization, real-world implementations consistently show measurable improvement when orchestration supplants manual workflows.
For example, one large pharmaceutical organization reduced order cycle time by 62 percent by automating identity management, workflow handoffs and quality review processes. At another leading biopharma, digitizing data exchange across functions reduced integration lead times for critical processes from 20 to 30 minutes to approximately one minute, which minimized bottlenecks.
A Tested Framework for Introducing Digital Orchestration Early
The framework I developed follows a five-step sequence in which order matters more than tools. It begins with identifying the transition points that can prevent a patient from being treated: collection, receipt at manufacturing, start of production, release, and final dispatch.
Before digitizing anything, the fundamentals must be standardized—controlled label templates, structured forms, release checklists, and clearly defined ownership of approvals. Digitization then focuses on the highest-risk steps first: e-signatures, dual patient identifiers, scan-to-verify custody transfers, and courier tracking tied to a unified patient identifier. Only after deviations begin to decline and cycle times stabilize does broader integration into LIMS, MES, ERP, and analytics platforms make sense.
Initial implementations should emphasize identity enforcement, custody logging, controlled labeling, guided workflows with documented safety justifications, automated deviation alerts, audit records, and direct logistics integration to facilitate early detection of delays.
In my experience, the most effective early-stage systems are modular, cloud-based, patient-centered, and designed specifically around high-risk transitions rather than abstract strategic roadmaps.
Strategic Growth Implications
As CGT pipelines expand, digital maturity increasingly distinguishes programs prepared for sustained scale. Structured orchestration preserves institutional knowledge, accelerates onboarding, and reduces dependency on informal communication channels.
A well-designed digital backbone also signals operational resilience to investors and external stakeholders. When processes are traceable, inspection-ready, and consistently executed, organizations show they can scale patient volume and expand their ecosystem without introducing new risk.
Cell and gene therapy manufacturing operates within narrow scientific, regulatory, and operational tolerances. Building the digital backbone early ensures that life-changing therapies reach patients safely, reliably, and without avoidable delay.
What This Means for ERP Insiders
Operational maturity becomes a gating factor for clinical scale. Scientific progress no longer defines program velocity once therapies enter production. Organizations that cannot coordinate identity, custody, and timing across systems will slow expansion regardless of clinical readiness.
Digital fragmentation shifts risk from visible to systemic. Disconnected tools do not just create inefficiency; they obscure where accountability resides across partners and workflows. This makes failures harder to detect early and more difficult to correct without disrupting treatment timelines.
Early infrastructure decisions define long-term economic viability. Cost pressure in CGT is often attributed to therapy complexity, but operational design plays a larger role over time. Systems that reduce rework, delays, and coordination overhead directly influence margin sustainability at scale.
Monika Birdi is the global product strategy leader for SAP’s Cell and Gene Therapy Orchestration (CGTO) platform.
