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Biopharmaceutical Production and Development Unit (BP&DU)

The Biopharmaceutical Production and Development Unit (BP&DU) supports research-associated topics:

Group 2022 more

Group in 2022

  • Large Scale production of purified parvovirus (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 and possible market release.
  • Large scale (up to 5 Liter) production and purification of parasites non GMP- DNA
  • Divers immunological- biological- and molecular-biological assays (e.g. ELISA, potency, qPCR, endotoxin, stability, deactivation) with standardized SOPs
  • Consulting and technical support for production-related inquiries
  • Accompanying research in two ParvOryx clinical trials with patient tumor and shedding analysis (see: Research - Treat (
  • Stability studies for possible drug candidates
  • In the establishment of GMP-produced parvovirus, the unit plays a pivotal role in the interaction with various organizations involved in the approval and application of procedures for virus (vector) production under GMP and GLP-conditions. Cooperations with GMP company (IDT Biologika GmbH) and GLP companies (Biogenes GmbH, Eurofins GmbH, Labor Enders & Kollegen)

Focus of the group lies in:

  • Virus production upstream optimization concerning virus yield and concentration
  • Downstream optimization according to impurity profile (empty virus particles, protein, DNA)
  • Qualified and validated analysis (quantity and quality)
  • Good process control
  • Process development including upscaling
  • Safety assessment (i.e. establishment of optimal deactivation protocols)
  • Consideration of ecological and economical aspects
  • Statistical experiment planning using Design of Experiment approach


Upstream process:

  • Micro and Macrocarrier up to 2.5 Liters for adherent cells
  • Suspension (shaked or stirred) Bacteria and Parasites cultures up to 5 L
  • Production in 10-layer Cell factories (6360 cm², Corning) or fixed bed bioreactor (4 m²) iCellis nano (Pall) For detailed description see Leuchs et al 2016 and Wohlfarth et al 2021


Downstream process:

  • Clarification (centrifugation, filtration with diverse filters up to 0.2µm)
  • Chromatographic purification with ÄKTApure (Cytiva). For H-1PV purification see Leuchs et al 2017
  • Stability testing as well as establishment of optimal deactivation protocol of H-1PV in regard to regulatory requirements
  • Sterile filtration and final Formulation

Specific qualitative and quantitative Analysis:

  • Metabolite analysis (Glucose, Lactate, Ammonia, LDH, etc.) with CEDEX Bio analyzer (Roche)
  • Cell and cell cycle characterization with Nucleocounter (Chemometec)
  • Photometric, fluorometric and luminometric analytical methods with FLUOstar Omega (BMG Labtech) for e.g. ELISA, immunoassays, protein-, DNA analysis

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