Our Client

The client is one of the world’s leading pharmaceutical major and a pioneer in Cell & Gene Therapy, delivering highly personalized CAR-T (T-cell) therapies to patients across multiple regions. Each therapy is autologous and manufactured from an individual patient’s own cells. It places extraordinary demands on identity integrity, chain of custody, and time-critical cryogenic logistics. To deliver these therapies safely and at a scale, the organization must coordinate a complex ecosystem. This comprises of doctors’ offices, leukapheresis centers, transportation providers, manufacturing sites, hospitals, and treatment centers, all under stringent regulatory oversight.

Industry Trends

The Cell & Gene Therapy market is reshaping how supply chains are designed and governed:

• Shifting from mass-produced pharmaceuticals to personalized, autologous “one patient, one batch” therapies where every unit is unique and irreplaceable.
• Elevating digital chain-of-custody and patient-identity protection from a compliance checkbox to a clinical safety imperative.
• Demanding real-time cold-chain visibility across cryogenic, time-critical vein-to-vein logistics.
• Requiring regulatory-ready platforms that embed GMP, HIPAA, and GxP controls rather than bolting them on.
• Pushing manufacturers toward scalable, standardized digital foundations that can be deployed rapidly across sites and geographies.

Challenges

The manufacturer faced significant operational and technical barriers to running personalized CAR-T supply chains safely at scale:

• Fragile identity integrity: Highly personalized workflows created constant risk of sample mix-ups, with no unified digital chain of custody from apheresis to infusion.
• Limited supply-chain visibility: Location, temperature, transit time, and handoffs were tracked manually, leaving little ability to intervene when cryogenic, time-critical shipments deviated.
• Complex multi-stakeholder coordination: Manufacturers, labs, hospitals, and logistics partners operated across regions without centralized monitoring, notifications, or capacity planning.
• “One patient, one batch” scaling constraints: The personalization that makes CAR-T effective also makes it hard to scale order planning, slot scheduling, and capacity management.
• Heavy compliance burden: GMP, HIPAA, and GxP requirements demanded controlled digital workflows, audit trails, and secure patient-identity management at every step.

LTM's Solution

LTM deployed an end-to-end CAR-T Commercial and Clinical Digital Platform on SAP BTP, orchestrating the full vein-to-vein journey as a single governed workflow. The out-of-the-box, SAP-certified solution addressed every dimension of the challenge:

• Digital Chain of Custody & Patient–Sample Traceability: Digitally tracked patient samples from apheresis to infusion, ensuring chain of custody, identity protection, and zero mix-ups across highly personalized CAR-T workflows.
• Real-Time Cold-Chain Visibility: Delivered real-time visibility of sample location, temperature, transit time, and handoffs, with automated alerts for deviations, enabling timely intervention in cryogenic, time-critical logistics.
• Clinical & Commercial Relationship Management: Unified site setup and onboarding, case management, patient enrolment and tracking, and treatment support across the patient journey.
• Supply Chain Orchestration: Streamlined order management, slot management, and regional capacity planning to support scalable operations despite “one patient, one batch” constraints.
• Integration & API Layer: Connected enterprise systems (MES, ERP, eLIMS, QMS) and external vendors (courier, transportation, specialty distributor, benefit verification, EMR/EHR) into one information and material flow.
• Data Management & Governance: Provided patient de-identification, a patient data hub, and reporting and analytics - with regulated, controlled digital workflows, audit trails, and secure patient-identity management.

Tech Stack

SAP Business Technology Platform (SAP BTP), SAP-certified T-Cell / Cell & Gene Therapy orchestration solution.

Business Benefits

• 100% patient-sample traceability across the CAR-T supply chain, safeguarding identity integrity end to end.
• Deployment in 3–4 weeks on SAP BTP with no customization, integrations across MES, LIMS, QMS, and clinical RTSM. accelerating time-to-value for Cell & Gene Therapy manufacturers.
• Regulatory-ready by design, meeting GMP, HIPAA, and GxP requirements through controlled workflows and audit trails.
• Faster, safer interventions in cryogenic logistics via real-time monitoring and automated deviation alerts.
• Scalable multi-stakeholder coordination through automated notifications, centralized monitoring, and cross-region capacity planning - improving readiness across manufacturers, labs, hospitals, and logistics partners.
• A reusable, standardized foundation for global delivery, with stronger data, analytics, and reporting capabilities across the patient journey.

Conclusion

Our team, with deep domain expertise in healthcare and life sciences, replaced fragmented tracking with end-to-end digital orchestration on SAP-certified platforms. Thus, LTM gave a global pharmaceutical major the ability to prove “one patient, one batch” integrity across the entire CAR-T lifecycle. The solution unified clinical, commercial, and supply-chain workflows into a single regulatory-ready platform. As a result, the solution delivered 100% traceability, real-time cold-chain visibility, and rapid, scalable deployment. With LTM as their Business Creativity partner, the client now has a proven, reusable foundation to scale personalized cell and gene therapies safely, compliantly, and at speed, because in CAR-T, getting it right the first time is the only option.