Validation and standardisation of analytics in downstream bioprocessing of rAAV vectors

PROJECT DESCRIPTION 

This project is situated in the bioprocessing of adeno-associated viral vectors. The objectives of the project are: (1) To generate and characterise standard materials for rAAV critical quality attributes (CQA) – viral titer & capsid content (i.e. capsid and DNA payload). (2) To validate various analytical methods that can feed back into the production process and help expedite process development. The project will provide skills in the field of vector productions and quality control for gene therapy applications and will allow the candidate to acquire expertise in both the academic and industry environment. 

A successful project will result in: (1) Standards for empty, partially full and full capsids of three different rAAV serotypes. (2) Tools and analytical techniques to generate and characterise these standards. (3) Comparison of different established methods for capsid content determination, i.e. ddPCR/ELISA ratio, Stunner, AUC, HPLC-SEC MALS, Gator BLI, using the developed tools.

Enrolment in Doctoral School: KU Leuven

Planned secondments:

• Aristotle University of Thessaloniki, Greece (Month 23): modelling techniques, PCA and estimation theory

• UCB, Belgium (Months 35-40): adapt analytical assays to pharma standards