6 ERP “Must Haves” for Tracking Chain of Custody within the Autologous CGT Industry 

February 15, 2024

In the autologous* cell and gene therapy (CGT) industry, tracking the path from patient to product is not just a regulatory requirement; it’s at the heart of patient safety and product integrity. An Enterprise Resource Planning (ERP) system plays a crucial role in this process. 

*(Lonza does a nice job of explaining the difference between autologous and allogeneic cell therapies here.)  

Here are six essential features an ERP system should possess to ensure a reliable chain of custody:

  1. Patient Data Management and Sample Control 
  2. Supply Chain Optimization 
  3. Storage Controls 
  4. Electronic Batch Records
  5. Real-time Tracking and Traceability  
  6. Dynamic Demand Forecasting 

Patient Data Management and Sample Control 

Patient sample control is the cornerstone of chain of custody in cell and gene therapy manufacturing. An ERP must not only store and manage patient data but also match each sample with its specific production run. Mistakes, such as using the wrong sample or vector, are not just costly—they can also mean a life-or-death situation for the patient. The ERP system must offer a robust method to validate each sample used, ensuring that such errors are avoided. 

From the moment a patient’s sample enters the manufacturing facility, its identity, tracked via the Donor Information Number (DIN), becomes critical data. The ERP system should track the DIN from the moment it is logged in the system to the point the final product is dispatched. This tracking encompasses every stage of processing, handling, and storage, providing a clear and auditable trail.

Learn more about Merit for Life Science’s batch track and trace functionality.

Supply Chain Optimization

For autologous therapies, the clock starts ticking as soon as a sample is received. In this time-sensitive environment, manufacturers need an ERP that’s both nimble and agile. The system should ensure rapid yet accurate processing, avoiding the complexities of a Manufacturing Execution System (MES) when not needed. The goal is to have an electronic system that offers necessary controls without the weight of cumbersome features. 

Learn more about Merit for Life Science manufacturing/production floor functionality.  

Storage Controls 

Storage conditions are critical in maintaining the viability of cell and gene therapies. An ERP must accurately validate temperature, humidity, and other environmental factors that could impact sample integrity. This not only ensures compliance but also maintains the biological efficacy of the products being manufactured.  

Electronic Batch Records

As part of tracking the chain of custody, an ERP system must provide a framework for aliquoting precise quantities of patient samples. This is a delicate process where precision is non-negotiable. The ERP should integrate these details into the electronic batch records, maintaining an unbroken record from sample division through to final product. 

Learn more about electronic batch reporting with Merit for Life Science.  

Real-time Tracking and Traceability  

Visibility throughout the supply chain and knowledge of process capacity are vital. An ERP system should give you a clear view of where your inputs come from, their status, and how they move through each step of the manufacturing process. It should also help you understand your production capabilities to plan and execute without over- or underutilizing resources.

 Learn more about Merit for Life Science inventory controls. 

Dynamic Demand Forecasting 

Finally, in the rapidly evolving field of cell and gene therapy, flexibility is key. The ERP system must accommodate the dynamic nature of bills of materials which can change from one batch to another. The software chosen should support your company through product development and preclinical activities without hindering progress when transitioning to commercial-scale production. 

With Merit for Life Science, you can manage and ensure the quality conditions of materials – from raw ingredients to end products – every step along the way.

Learn more about quality planning in Merit for Life Science.

Choose a Trusted Partner and Deliver Life-Saving Treatments with Confidence  

Selecting the right ERP system is not just about checking boxes on a list of features. It’s about finding a solution that fits the unique requirements of autologous cell and gene therapy manufacturing—a partner that understands the urgency and precision needed to deliver life-saving treatments to patients. The right ERP will align with your operational workflow, enhance your compliance posture, and support your mission to deliver therapies safely and effectively. 

Your next step is as easy as a conversation. Contact a Merit Solutions team member today.