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Vector Production & Development Unit (VP&DU)

Introduction

Group 2018 more

Group in 2017
© 2018 Tom Holz (t.holz@dkfz.de)

The VP&D Unit supports research-associated groups on two levels:

  • Large Scale production of purified virus (vector) stocks for preclinical applications or basic research
  • 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.

Aim

  • High virus yield and concentration
  • High purity
  • Precise analysis (quantity and quality)
  • Good process control
  • High safety
  • Process development including upscaling

Task

  • Standard large-scale production of purified, well characterized virus stocks of wildtype and recombinant parvoviruses.
  • Accompanying research for clinical studies.
  • Consulting and technical support intern by questions to virus production, purification and analysis.
  • Optimization and adaptation of production and purification methods.

Beside providing support for scientists our aim is to establish standard protocols for:
(a) self-replicating wild type and mutant parvoviruses and
(b) recombinant autonomous and adeno-associated parvoviruses carrying foreign therapeutic genes.

These new developments concern:

  • 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), 
  • up-scaling of the currently used procedures (evaluation of suitable production factories, adaptation to suspension/micro-carrier cultures), 
  • 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), 
  • 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.

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