Protein analysis

Protein

Innovative Technology Support Group for Life Science and Drug Discovery

PC5-1

PC5-1 : Intact M.W Determination by LC-MS

Test Introduction

Protein Molecular weight can provide important information regarding therapeutic protein, such as primary structure and post-translational modifications. The measurement of intact molecular weight is required by ICH Q6B guidelines. Intact M.W is determined using MALDI-TOF MS and LC-MS. Analysis can be conducted using electrospray (ESI) mass spectrometry which gives very accurate M.W determinations and has an effective ability to resolve the multiple isoforms caused by variation in post-translational modifications (e.g. different glycoforms). We use LC-MS as the default method for intact mass measurement, and report the molecular weight and ratio of each protein entity detected by an online LC-MS system.

Analysis Process

  • Biosimilar
  • Biobetter
  • Antibody
  • Antibody-drug conjugates
  • Recombinant protein drug
  • Toxin
  • vaccine

Test Method

  • Protease Digestion
  • LC-MS or MALDI-TOF
  • Characterization of peaks
  • Intact M.W determination
    - Native form
    - De-glycosylated form
    - Reducing form

Analysis Result