Solution
CellExpand
Cell Culture and Scale-Up Expansion Services
CellExpand is DrSignal Biotechnology's cell culture and scale-up expansion service, covering the full workflow from primary cell banking and medium optimization through closed bioreactor expansion to harvest and filling. The service runs in an ISO Class 7 cleanroom environment under a GMP quality system, with a single-batch expansion scale of up to 50 liters, while inline sensors monitor pH, dissolved oxygen and cell density in real time to ensure batch-to-batch consistency.
Primary Cell Banking & Activation
Primary Cell Banking and Activation
Client-supplied tissue or cells are isolated and purified in a biosafety cabinet. After passing viability and sterility testing, master and working cell banks are established, with backups preserved by controlled-rate freezing. Every operation is bound to a barcode and its timestamp recorded automatically.
Closed-System Scale-up
Closed-System Scale-Up Expansion
Suspension or adherent expansion is carried out in a closed bioreactor, with culture parameters adjusted automatically by the process control system to reduce manual intervention and contamination risk. After expansion, cells are concentrated, washed and aliquoted within a closed circuit, with no open exposure at any point.
Service Process
From the requirements interview to product delivery, the service runs through eight stages. Every batch carries a unique lot number bound to its process records, and clients can check growth curves, test reports and release documents through a dedicated account.
Requirements Interview and Solution Design
Cell and Document Intake
Master Cell Bank Establishment
Medium and Parameter Optimization
Closed-System Expansion
Inline Quality Monitoring
Harvest, Concentration and Filling
Release Testing and Delivery
Service Advantages
Closed System Reduces Contamination Risk
From cell intake to filling, the entire process takes place in closed tubing and closed bioreactors, reducing open-handling exposure and markedly lowering contamination rates compared with traditional open culture.
Inline Process Monitoring and Parameter Feedback
pH, dissolved oxygen, temperature and cell density are logged every minute. The process control system adjusts automatically within the configured ranges and retains full trend charts for audit.
Batch-Traceable Quality Documentation
Every batch is fully documented, from raw materials and medium lot numbers to operators and equipment. Records meet electronic records and electronic signature requirements, and the process history can be traced back ten years.
CellExpand Service Guide
PDFCovers the scope of service, expansion specifications, the quality system and the commissioning process.