CellBase CT - for ex-vivo expansion of autologous cell therapy productsTAP Biosystems
CellBase CT is a new automated system designed for ex-vivo expansion of autologous cell therapy products.
Developed with leading cell therapy organisations, CellBase CT scales up existing manual cell culture processes in T-flasks, enabling manufacture of cell therapy products derived from a wide range of cell types, including hES, iPS and adult stem cells.
CellBase CT automates:
CellBase CT automates the maintenance and expansion of cells in T-flasks from multiple patients in a contamination-free, aseptic environment.
• Maintains separation of individual cell therapy products in T-flasks via highly controlled processing including: feeding, incubation, passage and harvest
• Uses automated microscopy to make accurate measurements to trigger cell harvesting at optimal cell confluency
• Includes precise counting and viability measurement of cell suspensions prior to seeding and for output
• Provides tracking via unique flask bar codes and audit trail of all process steps for each individual patient cell therapy product
CellBase CT is provided with a range of tools to support validation in GMP regulated laboratories.
CellBase CT offers:
CellBase CT offers a secure, readily scalable alternative to labour intensive manual cell culture for the manufacture of cell therapy products.
• Provides aseptic processing environment to protects cell therapy products from contamination and cross-contamination
• Allows scale up of production to support larger scale clinical trials and manufacturing without process change or need for regulatory re-approval
• Fully automated process using standard T flasks allowing unattended operation overnight and at weekends
• Consistent, high quality output of cells of multiple individual patient products in parallel from a single system
• Standardised solution to support validation of the system for GMP regulated production
CellBase CT provides a restricted access barrier system under negative pressure to provide both protection of the operators and an effective barrier to ensure aseptic processing of the products.
• Process development to optimise cell culture process and reduce cost of goods
• Production of clinical material to support Phase II and Phase III trials
• Ex vivo expansion of cells for commercial manufacture of autologous cell therapy products