Vector Production & Development Unit (VP&DU)
Table of Contents
The VP&D Unit supports research-associated groups on two levels.
(i) Large Scale production of purified virus(vector) stocks for preclinical applications or basic research and
(ii) development and optimization of new production, purification and analytic methods with the aim to establish working protocols for GMP-production of virus(vector) stocks necessary for clinical applications planned in the department F010.
-> High virus yield and concentration
-> High purity
-> Exact analysis (quantity and quality)
-> Good process control
-> High safety
- Standard Large-scale production of purified, well characterized virus stocks of wildtype and recombinant parvoviruses (Standard-Process)
- Optimization and adaptation of production and purification methods:
(a) self-replicating wild type and mutant parvoviruses and
(b) recombinant autonomous and adeno-associated parvoviruses carrying foreign therapeutic genes. These new developments concern
(i) the improvement of distinct steps in the production and purification protocols (e.g. evaluation of initial titers for virus production [optimization of per cell output], optimizing transfection procedures [cost factors included], search for suitable cell lines for optimal production),
(ii) up-scaling of the currently used procedures (evaluation of suitable production factories, adaptation to suspension/micro-carrier cultures),
(iii) the establishment of new procedures for virus purification and quality controls (concentration of virus stocks, purification by alternative/additional purification steps [e.g. affinity chromatography], establishment of quality control measurements, (SDS-PAGE, HPLC/FPLC, Empty capsid vs. full capsids by ELISA-techniques),
(iv) adaptation of present materials and methodologies to the production of GMP-grade virus (vector) stocks to support clinical trials.
In the establishment of GMP-produced parvovirus, the unit also plays a pivotal role in the interaction of the F010 division with the various organizations involved in the approval and application of procedures for virus(vector) production under GMP-conditions.
Therefore BASIC REQUIREMENTS and CONDITIONS are necessary.