Traceability is acritical part收集，细胞和基因疗法的制造和分布。Werum IT Solutions，制造执行系统（MES）和制造IT解决方案的制药和生物技术解决方案的供应商正在与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.”
“我们将共享知识和资源，以开发细胞和基因疗法的端到端供应链管理解决方案，以整合制造和物流，从而为患者提供此类疗法的复杂过程，” Andreas Fischer博士说。Werum IT Solutions的业务部门Safecell主管。
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.
