Hypertrust
X-Chain

End-to-end supply chain management for Advanced therapy medicinal products (ATMPs) in one single solution.

Compared to traditional medicines, the supply chain management of personalized medicine is drastically more complex, requiring specific temperatures, rigorous quality standards and coordination. Hypertrust X-Chain allows customers to invest their expertise directly in the success of their therapy instead of being burdened with background processes.

Key Facts

Patients Onboarded

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Therapy Supply Chain Workflows Implemented

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Different Manufacturing Models Covered

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All in One Solution

X-Chain Modules

The different modules of Hypertrust X-Chain are configurable and scalable to support supply chain needs of different stakeholders.

Large pharmaceutical enterprises with an established supply chain infrastructure can leverage Hypertrust X-Chain as a complementary full-service mix-and-match supply chain management solution for Advanced therapy medicinal products (ATMP). To small and mid-sized biotech/pharma companies, Hypertrust X-Chain delivers an end-to-end solution out of one hand. It supports central manufacturing, decentralized manufacturing models or even a mixed setup.

Supply Chain Network Designer

Workflows, master data, product specific constraints, clinics & centers as well as 3rd party services together form therapy specific supply chain networks. Use our Designer module to model dedicated supply chains as a core component for strategic decisions and operational implementations.

Supply Chain Simulations

Based on created Supply Chain Network models our Supply Chain Simulations module generates valuable insights about to be expected KPIs, like e.g., supply chain capacity (treatments per time period), and the impact of parameter changes on different stages of a therapy cycle.

Labeling

Our Labeling module not only offers standardized formats like ISBT-128 ST-018 for collection products, but also the freedom to create arbitrary labels for samples, intermediate and final products according to variable requirements.

Manufacturing Execution System

Our Manufacturing Execution System (MES) module offers a highly integrated mechanism to instruct and monitor manufacturing operators based on validated SOPs and a resulting consistent batch record. At the same time, we revolutionize the operator’s user experience through a combination of latest visualization technologies (like Augmented Reality) paired with industry proven and highly optimized data input methods.

Electronic Batch Record

Electronic batch record data is an integral part of the platform, as it forms the backbone of a consistent chain of custody. Depending on the details of the used Supply Chain Network model, data is retrieved from our MES module, from connectors to external Manufacturing Execution Systems or from both.

Document Management

Our Document Management module can be used as a highly integrated alternative to external systems. Storage and access to therapy related documents like SOPs, CoAs, Labels and others will automatically adhere to the same authorization policies and data protection regulation settings configured for the therapy when using our module.

Cross-Company Integration & Collaboration

The core of a successful therapy orchestration is cross-organizational scheduling. Use our modules Cross-Company Schedule Management, Cross-Company Capacity Management, Cross-Company Scheduling and Cross-Company Integration & Collaboration to build a powerful operational planning engine.

Methodology

The C&GTO Methodology

As the field of Cell and Gene Therapy (CGT) supply chains continues to advance, there arises a need for specialized tools that can effectively manage the complexities associated with it. This is where the Cell & Gene Therapy Orchestration Platform (C&GTO) comes into play. Much like how standardized terms, principles, and methodologies were established for Material Requirements Planning (MRP) and Enterprise Resource Planning (ERP) systems in the manufacturing sector, a similar evolution is now required for CGT supply chain orchestration.

Just as MRP systems evolved into comprehensive ERP systems to handle a wide array of enterprise resource planning aspects, CGT supply chains are also evolving to demand specialized Orchestration Platforms. The realm of Cell & Gene Therapy Orchestration has distinct levels, each with its own underlying layers:

Strategic Level

Supply Chain Network Designer. This level involves the strategic planning of the CGT supply chain network.

Tactical Level

Supply Chain Simulations. Here, tactical planning and simulations to optimize the supply chain are carried out.

Orchestration Level

The core of the Cell & Gene Therapy Orchestration concept resides here, encompassing:

Supply Chain Protocol Execution
Workflow Management
Chain of Identity and Custody

Operational Level

This tier is further divided into various components, including:

Cross Company Schedule Management
Cross Company Capacity Management
Cross Company Scheduling
Cross Company Integration & Collaboration

Manufacturing Level

At this level, the focus shifts to manufacturing-related aspects, including:

Manufacturing Execution System
Labeling
Electronic Batch Record
Document Management

The C&GTO Concept

All these levels, spanning from the long-term strategic planning down to the short-term operational activities, are integral components of the holistic C&GTO concept. The C&GTO concept revolves around the orchestration level, where cross-company workflows and data management take center stage. Moreover, it’s intricately linked to higher-level supply chain planning and seamlessly interfaces with day-to-day manufacturing operations. Each level is equipped with the appropriate layers necessary for translating strategic goals into actionable solutions.

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