Traceability is a critical part of the collection, manufacturing and distribution of cell and gene therapies. Werum IT Solutions, a supplier of manufacturing execution systems (MES) and manufacturing IT solutions for pharma and biotech, is partnering with Blood Centers of America (BCA) to provide a standardized, scalable, and compliant platform for the cell and gene therapy market. BCA is a member-owned organization comprised of over 50 independent blood centers throughout North America, representing nearly 40% of the U.S. blood supply.
The two partners will jointly develop a seamless digital supply chain solution suite for cell and gene therapy. It will be designed to integrate manufacturing and supply chain logistics as well as the collection of autologous/allogenic cell-based raw material in the manufacture of cell and gene therapies. The cell and gene market will benefit from standardized processes, scalability of their products, full control of the chain of compliance, and electronic batch recording, according to Werum IT solutions.
“We are excited to partner with Werum IT Solutions,” says Charles Mooney, VP Bio-Development & Quality Management at the Oklahoma Blood Institute and BCA Cell Therapy Committee Chair. “To efficiently manage cell and gene therapies the market needs a comprehensive ‘vein-to-vein’ IT solution that we will create together with Werum—a novelty and important milestone in the cell and gene business.”
“We will share knowledge and resources in order to develop an end-to-end supply chain management solution of cell and gene therapies integrating manufacturing and logistics for the complex process of delivering such therapies to the patient,” says Dr. Andreas Fischer, Senior Head of Business Unit SafeCell at Werum IT Solutions.
In this context, Werum’s PAS-X MES will play a role in tracking and controling each patient’s material. PAS-X is designed to provide one GMP-compliant electronic batch record allowing real-time data access and analysis, increasing data quality, and reducing per batch execution effort and risk of human error.