Cell and gene therapy (CGTs) offers significant advances in patient care by helping to treat or potentially cure a range of conditions that have been untouched by small molecule and biologic agents. Over the past two decades, more than 20 CGTs have been approved by the FDA in the United States.1 But there are challenges in bringing these therapies to market, including how to make them, how to analyze them, and how to ensure they can be produced with reliability and quality.2
A new case study, Project A-Cell, highlights best practices and a standard methodology for Chemistry, Manufacturing and Controls (CMC) to the cell-based therapy field. The guide speaks to the importance of enterprise control – and the critical systems that enable this control in cell-based therapy manufacturing. One of these systems is Process Information Management (PIMS), which is designed to ensure robustness of the CGT manufacturing process.
Sponsored by the Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing BioPharmaceuticals (NIIMBL), Project A-Cell is a multi-stakeholder collaboration and includes input from IDBS Senior Director of Product Strategy, Ken Forman, and Director of Strategic Solutions, Marc Smith. Central to their message is that data systems, like IDBS Skyland PIMS, are key to the collection, storage, analysis and sharing of critical manufacturing data for monitoring, understanding and optimizing complex cell therapy production. In the context of cell therapy manufacturing, PIMS software can be deployed for process monitoring from the collection of blood components during apheresis through cellular therapy to clinical endpoint data.
Skyland PIMS supports adherence to regulatory authority requirements, like continued process verification (CPV), by efficiently generating analytics for monitoring and reporting as well as supporting investigations. Skyland PIMS is unique as it is designed to easily curate data from paper, spreadsheets, and finally, digital data sources as the organization’s digital infrastructure matures.
In the guide, Forman and Smith describe vein-to-vein (V2V) management, as one area where PIMS can be highly beneficial in cell-based therapy. In this situation, it enables the linking of blood characteristic information collected from blood donations, the resulting processed therapeutics’ quality information, and non-patient identifying efficacy data from hospital medical records. The result is increased visibility into how therapies are performing in addition to any possible correlations with adverse effects due to manufacturing quality problems or raw materials.
Cell and gene therapy manufacturers are increasingly selecting Skyland PIMS as their cornerstone process information management platform to support clinical production, drive tech transfer, and accelerate commercialization. PIMS is a high-value, yet easy-to-deploy, cloud-based data information management system delivering an 83% increase in productivity versus error-prone and labor-intensive spreadsheets. With PIMS, teams can rapidly collect, analyze and securely share critical process data to improve understanding and control of performance. From clinical phase through commercialization, PIMS accelerates the transfer of historical and ongoing process and product knowledge, quickly advancing development and shortening time for CMC and CPV.
Learn more about how leading cell therapy manufacturing organizations use #SkylandPIMS to accelerate development and manufacturing success.
- Project-A-CELL case study
- Growth in Cell and Gene Therapy Market, Cleo Bern Hartley, BioPharm International, Oct. 1, 2022.
- Coming Together to Enable Cell and Gene Therapy Manufacturing, Jennifer Markarian, BioPharm International, June 1, 2022.