CellBase
CT has been developed with leading
cell therapy organisations to automate the
maintenance and expansion of multiple patient
products in an aseptic processing area.
The system enables development and manufacture
of cell therapy products derived from a
wide range of cell types, including hES,
iPS and adult stem cells and comes with
a range of tools to support validation in
a GMP regulated environment.
The ideal time to implement
CellBase CT is during Phase II, when cell
therapy products can be tested alongside
manually produced material so that phase
III can be fully supported by the automated
platform. The simple scalability of the
system means that the CellBase CT process
technology can be used throughout development
and into production, reducing the high level
of risk and cost associated with the need
to prove equivalency following late stage
process changes.
Cellmate
has been installed in over 80 sites around
the world for batch production of biologics,
process development and research.
Cellmate is used for producing
large quantities of cells for cell therapies.
Cellmate allows the flask based (T flasks
and roller bottles) manual culture processes
to be scaled up from research to production
without process change: shortening development
times, reducing infrastructure requirements
and simplifying validation for products
that are difficult or impractical to transition
in to large scale bioreactor production.
Avigen
chose Cellmate
to help manufacture an adeno-associated
viral vectored gene therapy product
to be used in clinical trials
