Tracking Cell Therapy Chain of Identity

Cell therapy is when:

…cellular material is injected into a patient;[1] this generally means intact, living cells. For example, T cells capable of fighting cancer cells via cell-mediated immunity may be injected in the course of immunotherapy.

Emerson's Michalle Adkins


For manufacturers in the Life Sciences industry, making these therapies poses challenges since each batch is specific to a given patient. In this 2:25 YouTube video, Address Cell Therapy Batch Production Challenges with Syncade, Emerson’s Michalle Adkins shares how operations management technology plays an important role in addressing these challenges.

Michalle opens noting a big challenge is making sure that the right batch gets to the right person. This is known as chain of identity in industry parlance.

The manufacturing process begins in a clinical setting where the cells—from blood, tumor or other types of cells are collected from the patient. These cells are transported to the manufacturing facility where they are isolated and ready for the specific therapy to be made.

Tracking this movement from patient to cell therapy production process and back to patient is critical. This challenge is above and beyond the challenges for other pharmaceutical production processes such as tracking the addition of the proper materials into the batch in the correct amounts and sequence required by the batch, ensuring that the equipment is in the proper state when it is needed by the batch, and ensuring operators are properly trained.

Michalle explains how the cells from the patient are placed in barcoded packaging to begin the process of tracking their path through the production process. The operators use these barcodes to make sure they are working on the right batch. The records associated with the barcodes also give the workflows needed by the operators to correctly make the batch.

These electronic workflow instructions help to have right-the-first-time, quality production performed. The Syncade manufacturing execution system (MES) helps users manage the chain of identity across manufacturing process and supply chain with the electronic batch records created as proof.

Visit the Manufacturing Execution Systems area of Emerson.com for more on ways to optimize the pharmaceutical and biotech manufacturing processes through the combination of document, equipment, and materials management into electronic work procedures. You can also connect and interact with other Life Sciences industry and operations management experts in the Life Sciences and Control & Safety Systems group in the Emerson Exchange 365 community.