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 cells and wide range of biological products including viral vectors, virus-like particles, viral-based vaccines, and recombinant proteins makes us an ideal partner for the most challenging projects.

Process Development:

VVector Bio has in-depth expertise and a dedicated staff of experts 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-yielding cell culture process is a critical stage for the effective manufacturing of a biological product.

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

In order to limit the 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 1 L, 3 L, and 10 L bioreactor scales.

Intensification strategies include:

  • 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 conduct feasibility and screening studies to develop robust, efficient downstream processes.

Thanks to our experience in clarification, concentration and chromatography, we deliver a 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