Vector Production & Development Unit (VP&DU)

-> 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.