In the autologous* cell and gene therapy (CGT) industry, tracking the path from patient to product is not just a regulatory requirement; it's at the heart of patient safety and product integrity. An Enterprise Resource Planning (ERP) system plays a crucial role in this process. *(Lonza does a nice job of explaining the difference between autologous and allogeneic cell therapies here.) Here are six essential features an ERP system should possess to ensure a reliable chain of custody: Patient Data Management and Sample Control Supply Chain Optimization Storage Controls Electronic Batch Records Real-time Tracking and Traceability Dynamic Demand Forecasting Patient Data Management and Sample Control Patient sample control is the...
How Merit for Life Science Meets Weighing and Dispensing Requirements
In this four-part blog series, we’ll explore how Merit for Life Science optimizes critical business processes for pharmaceutical and biotech companies. Watch for our other blogs on inventory management and product safety, inventory splitting and sub-batching, and controlling storage conditions. Weighing and Dispensing in Life Science Manufacturing Weighing and dispensing is a critical process for pharmaceutical and biotechnology manufacturers. These processes include removing specified amounts of bulk raw material from their source containers and dispensing specific quantities into other containers. Pharmaceutical and biotech organizations require that strictly controlled processes be used when materials are measured out or transferred between containers, in...