Process Development /

Analytical Methods Development

Analytical methods development

Biotechpharma´s Quality Control (QC) department is developing and performing analytical methods to ensure a high quality of the product,  by determination of quantity and purity of proteins in solution and identification of analytes inter alia by high performance liquid chromatography.

We perform:

  • LC analytical method development and validation;
  • Sample analysis applying RP, SEC, IE, NP, HIC stationary phases;
  • Protein peptide mapping method development;
  • Impurity profiling using liquid chromatography and 2D gel electrophoresis.

Main equipment:

  • 4 HPLC systems (Waters). Applied detectors:

UV-Vis detector

Multi λ Fluorescence detector

Evaporative Light Scattering detector

  • Ion Trap (Bruker)
  • 2D electrophoresis system (GE healthcare)
  • Western blot device (Amersham Biosciences)
  • SDS-PAGE electrophoresis device (Bio-Rad)
  • AKTAmicro chromatography system (GE healthcare)