Isolation Processes

BioTechLogic has experience managing pre-qualification and optimization studies for isolation and separation technologies. We have managed laboratory scale processes and large-scale processes up to 30,000 L scale. Our experience includes the development and validation of the following:

  • Precipitation
  • Centrifugation
  • Microfiltration
  • Depth Filtration
  • Cell Disruption (microfluidization, homogenization)
  • Periplasmic Extraction

 BioTechLogic accomplishments include:

  • Pre-Qualification activities for an antibody fragment produced at 10,000 L scale
  • RNA oligonucleotide synthesis process validated and FDA-approved for the second synthetically produced oligonucleotide
  • NDA approval and MAA positive opinion of a Growth Hormone Receptor Antagonist