DEVELOPING ROBUST SUPPLY CHAIN STRATEGIES USING PRODUCTION PLANNING & RISK MITIGATION FOR CLINICAL TRIAL ONBOARDING & IMPROVING PRODUCT QUALITY

• Published in: Cytotherapy (Oxford, England) England), 2024-06, Vol.26 (6), p.S141-S141
• Main Authors: Nisar, A., Pandit, K., Showkat, S., Bhamare, A., Naik, K., Guglavath, S., Narula, G.
• Format: Article
• Language: English
• Subjects: Chain of Identify & Custody; Quality Management System; Supply Chain Competency
• ISSN: 1465-3249; 1477-2566
• DOI: 10.1016/j.jcyt.2024.03.273

Supply chain competency is vital for navigating the complexities of Cell Therapy Products supply chains, encompassing transportation, product movement, temperature control, and coordinated delivery to ensure therapy quality.As CTP developers transition from PoC to late-stage clinical trials assessment of potential & risks associated with starting & ancillary materials becomes imperative considering their impact on the overall product & patient outcomes. The CART & Cell Therapy Centre (CTCTC) at Tata Memorial Centre, Mumbai, an Academic Clinical Manufacturing cGMP facility, focuses on patient-centric CTP production, necessitating robust supply chain capabilities for precise & timely treatment delivery. CTCTC has developed an Operating Model Management (OMM) module that handles complexities such as monitoring time & temperature sensitivity, ensuring a closed-loop supply chain, managing low-volume & high-value products, and providing end-to-end visibility, all managed through in-house auditing strategies. The closed-loop value chain also includes customized assays for viral vectors and apheresis of cells with each product batch monitored & tracked across the supply chain. A "make-to-order" model is deployed, incorporating product & patient labeling, ensuring end-to-end visibility and traceability. Documentation and labeling checks with unique identifiers (COI and COC) are maintained throughout the collection & product administration process. The obstacle of patient-specific batches is addressed through a decentralized supply chain approach, with precise scheduling for product safety. End-to-end integration is done through digital planning. Risk mitigation is achieved through incorporating technologies for monitoring, storage, validation, and backup, along with controlled access, material splitting across sites & quick response to alarms. Translation of technical supply chain logistics into user-friendly instructions is integrated into SOPs & robust QMS.Critical material management is ensured through a robust inventory management system with a full audit trail & traceability. Collaboration with suppliers involves establishing robust contracts upfront, including MSA, QAA, SOW, CO & a "clause library" for covering lead time, delivery, license agreements, regulatory requirements & non-performance penalties. To reduce logistical risks, CTCTC encourages the enrolment of new local providers, further strengthening the decentralized supply chain & OMM approach at CTCT