Process and Analytical development

AAV Process and Analytical Development

The Process and Analytical Development area will focus on the development and optimization of upstream and downstream processes for adherent and suspension processes to be scaled up and transferred to GMP manufacturing.

InnovaVector has Leading Scientific Team, world class Development expertise for gene therapy viral products.

This route provides potential access to InnovaVector unique and flexible platform for viral vector production : from feasibility to pre-clinical batches

Evaluation and optimization of productivity of selected Vector design (for pre-clinical proof of concept)

Example: Feasibility study at shake flask : determination of conditions for best productivity using a DOE-like approach

Analytics

Genome copy number determination (qPCR)
Infectious titer (Cell based assay)
Capsid titer (ELISA)
Full/Empty Capsid ratio analysis
Residual DNA quantification
Residual protein quantification
Vector capsid stoechiometry

Development/Evaluation of process at 2L scale (e.g. suitability for toxicological evaluation)

Example: Evaluation of productivity in bioreactor : development of Upstream process at 2L scale  
Example: Development of a Full Process USP / DSP at 2 L scale 

Process Scale-up and production of non-GMP batch:

Example: Scale up of the Upstream process from 2L to 50 L
Example: Production of 50 L batch

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