可追溯性是一个critical partof the collection, manufacturing and distribution of cell and gene therapies.解决方案, a supplier of manufacturing execution systems (MES) and manufacturing IT solutions for pharma and biotech, is partnering withBlood Centers of America(BCA)为细胞和基因治疗市场提供标准化,可扩展和兼容的平台。BCA是一个成员拥有的组织,该组织由整个北美的50多个独立血液中心组成,占美国血液供应的近40%。
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.
在这种情况下,Werum的PAS-X ME将在跟踪和控制每个患者的材料方面发挥作用。PAS-X旨在提供一个符合GMP的电子批次记录,可实时数据访问和分析,提高数据质量,并减少每批执行工作和人为错误的风险。