Presenter: Prof. Spyridonidis
Participants: Dr Liga, Dr Tsokanas
Duration: 40mins


Axicabtagene ciloleucel is an engineered autologous anti-CD19 chimeric
antigen receptor T cell therapy being developed for patients with refractory aggressive B-cell lymphoma. The product is manufactured in a central
facility from cellular starting material containing a patient’s own T cells
into which a chimeric antigen receptor transgene is directly introduced.
This cellular starting material is highly variable from donor to donor and
provides the single largest source of variability associated with the production process. Nonetheless, a robust manufacturing and distribution
process was developed based on process understanding and appropriate
process controls. Process characterization revealed process parameters
that affect quality attributes, allowing appropriate control measures to
be implemented. Process comparability criteria were also established as
another mechanism to ensure process consistency as new manufacturing sites were introduced. A relationship between cellular characteristics
of the incoming cellular starting material, cell growth and performance
during manufacturing, and the ultimate product characteristics after administration to patients is also beginning to come into focus.

Read the full article on Overcoming Challenges for Engineered Autologous T Cell Therapies