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Cell and Gene Therapy 2018 & Clinical Microbiology Congress 2018
Biomedical Research
|
ISSN: 0976-1683
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Volume 29
S e p t e m b e r 1 0 - 1 1 , 2 0 1 8 | D u b l i n , I r e l a n d
allied
academies
Joint Event on
CLINICAL AND MEDICAL MICROBIOLOGY
CELL AND GENE THERAPY
&
World Congress on
International Conference on
Biomed Res 2018, Volume 29 | DOI: 10.4066/biomedicalresearch-C3-008
ADVANCED APPROACHES FOR CELL THERAPY PRODUCT CHARACTERIZATION
Damian Marshall
Cell and Gene Therapy Catapult, UK
C
ell and gene therapy manufacturing process can be complex and have high level of raw material variability. This makes the development
of reliable, consistent and cost-effective manufacturing processes a significant challenge. For autologous products, this challenge can
be even greater due to the added variability of the patient specific cellular starting material and the lack of real-time process data. These
challenges could be addressed through the application of Process Analytical Technologies (PAT) that permit in-line or at-line analysis
throughout the manufacturing process. These technologies could allow key variables to be tracked for tighter process control as well as
the provision of process information in a time frame enough to allow proactive decision making and the early detection of poor process
performance. In this presentation we will show how in-line optical biosensors can be applied for advanced multiparametric monitoring of
cell and gene therapy bioprocesses. We will show how real-time process data can be used to support manufacturing decisions and the role
these technologies have in supporting a move towards feedback control and adaptive manufacturing.