Digitalization of Cellular Therapy Workflows: Revolutionizing the Next Generation of Therapeutics

For GMP CT manufacturing and administration, the most advanced market participants will leverage a single digital platform to coordinate the various supply chain steps and internal functions. This includes modules that facilitate collections, labeling, post-collection processing, transportation and logistics such as Chain of Identity (COI) and Chain of Control (COC), manufacturing, QA / QC and product release, as well as thawing and infusion. Clinical considerations add additional needs in the areas of recipient and donor management, post infusion outcomes and reporting. Systems that address each of the elements representative of a comprehensive Cell Therapy Software (CTS) system include:

• Learning Management Systems (LMS)

• Logistics management platforms

• Electronic Batch Record Systems (EBR)

• Manufacturing Execution Systems (MES)

• Electronic Quality Management Systems (eQMS) - including environmental data monitoring and data analytics for continuous monitoring

• Procurement / scheduling systems

• Document control