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Phage Development & Manufacturing

Cobra has experience with cell lines:

  • E.coli
  • S.aureus

Plus the following phage types:

  • Filamentous
  • Lamda
  • Lytic / non-lytic
  • Native / engineered

With production up to 50L scale in a fermentation system, plus chromatographic purification, Cobra provides process development and scale up of customers’ phage products including:

  • Master Virus Seed Stock (MVSS) production by plaque purification
  • Upstream processing optimisation including Multiplicity and Point of Infection (MOI / POI) optimisation
  • Point of Harvest (POH) optimisation
  • Fermentation development
  • Product delivery
  • Chromatographic purification for the removal of host contaminants
  • Formulation 

Cobra manufactures to cGMP standards for pre-clinical to clinical and commercial scale, providing Quality Assurance and regulatory support.
 
Our expert team also offers analytical development and qualification including:

  • Assay development and transfer
  • Product Characterisation
  • QC Release Testing
  • QC testing: Drug Substance and Drug Product
  • Cell based potency assays
  • Stability Studies to ICH guidelines: Drug Substance & Drug Product (forced degradation & pre-formulation studies)
  • Cleaning validation
  • Raw material testing

For more information, get in touch with our expert team today.

Other Viral Vectors Services...

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