Process Development

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Process Development

At VVector Bio we provide upstream (USP) and downstream (DSP) process development services based on a systematic approach using Design of Experiment tools. 

Our goal is to identify key process parameters to increase final product yields and critical quality attributes as well as reducing contaminants. 

We offer comprehensive and cost-effective process development supported by strong analytic methods. 

Our expertise in working with a variety of cell lines like HEK293, Sf9, CHO cells and wide range of biological products including viral vectors, virus-like particles, viruses or recombinant proteins makes us an ideal partner for the most challenging project.

Process Development:

VVector has in-depth expertise, and dedicated staff of expert to provide full upstream  & downstream  process development including:

  • Screening studies
  • Media evaluation
  • Cell line development
  • Product optimization strategies (yield increase and contaminant reduction)

Analytic Development:

  • Quantification (ELISA, ddPCR, protein assay, HPLC)
  • Cell based assay (GTA, TCID50)
  • Identity & Purity (e.g. qPCR, dd-PCR, western blot, SDS-PAGE, sequencing)
  • Residuals (ELISA, Host cell DNA contaminants, host cell protein contaminants) 

Upstream Process Development

The development of a robust and high yield cell culture process is a critical stage for the effective manufacturing of a biological product.

At VVector Bio high-throughput screening can be perform at various scale ranging from 10 mL tubespin; 20-50 mL shake flasks to fully controlled 250 mL mini-bioreactor (Ambr250).

 In order to limit cost and time of the project, Design of Experiments (DOE) is used as a tool to identify the critical process parameter.

Cell culture process validation can be operated at 1L , 3L and 10L bioreactor scale.

 Intensification strategies includes:

  • Development of batch, fed-batch and perfusion strategies
  • Host cell infection & transfection optimization

Capabilities:

  • Ambr 250 (6x)
  • 1 L Bioreactor (3x)
  • 3 L bioreactor (1x) (Applikon)
  • 10 L working volume in a Wave25 Bioreactor (Cytiva)

Downstream Process Development

At VVector Bio, we perform feasibility and screening studies to develop robust and efficient downstream process.

Thanks to our experience in clarification, concentration and chromatography, we deliver comprehensive downstream process ready for manufacturing transfer.

Expertise:

  • Chromatography (Affinity, Ion exchange, size exclusion)
  • Akta avant 25 chromatography system
  • Filtration, ultrafiltration, diafiltration (Depth filter, TFF-UF/DF)

VVECTOR BIO, Bridging Research and Clinic