BioAnalytical Development

BioTechLogic has experience developing analytical methods for proteins and macromolecules. Our process characterization and validation expertise enables us to integrate the role analytics plays in biopharmaceutical manufacturing. BioTechLogic has hands-on experience developing the following analytical methods:

  • Molecular PCR and Quantitative PCR
  • Sterility, Bioburden and Mycoplasma
  • DNA extraction
  • HPLC methods
  • Physiochemical methods

BioTechLogic has also managed third-party laboratories during the development, qualification, validation and transfer of residual, impurity and safety methods. We have worked with multiple contract laboratories to expedite analytical assay development for characterization testing needed to prepare for process validation. BioTechLogic has managed multiple method transfers of qualified and validated methods from contract laboratories to manufacturing sites.