Ex-vivo Expansion of Autologous Cell Therapy Products

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.Applications include:• 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