Vienna, Vienna, Austria
Implementation of a downstream manufacturing process (BAX826) in a newly established lab, including 3 column chromatography steps (BEC, HIC, SEC), 2 ultrafiltration steps and an initial chemical modification step. I personally focused on the establishment of semi-automated column packing and sanitization procedures, on the conduct of the chemical modification and the UFA steps and on drafting of MBRs, SOPs and equipment drawings. Successful engineering runs, GMP conversion and clincal phase III production of a chemically modified recombinant antihemophilic factor VIII.
Analytical method life cycle management, including method validation projects, monitoring of assay integrity (standards and reagents implementation, stability plans) and creation of various internal and submission document types such as: VPRs, CCRs, CTPs.
Development , validation and FDA BLA submission of a Fc function lot release assay (cell culture + ELISA). Earlier, conduct of different virological and serological lot release methods including haemagglutination, single radial diffusion, neutralisation assays and potency tests.
Engineering of chimeric T-Cell receptors including molecular cloning, transfection of T-cells, cell culture, gene sequencing.
Isolation and propagation of mesenchymal stem cells on microcarriers in bioreactors.