Host Cell Protein Impurity Identification using HRMS

GEL ELECTROPHORESIS

Electrophoresis is a technique that enables separation and analysis of charged molecules in an electric field. Gel electrophoresis is most commonly used for separation and purification of proteins and nucleic acids that differ in size, charge, or conformation. The gel is composed of polyacrylamide or agarose. Polyacrylamide is preferred for proteins and smaller DNA fragments.

GEL ELECTROPHORESIS

PROTEIN ANALYSIS BY PAGE

ICH Q6B requires electrophoretic patterns for the analysis of Biopharmaceuticals.

  • Protein size determination
  • Protein identification
  • Impurity profiling
  • Aggregate analysis

PROTEIN ANLAYSIS BY PAGE- CASE STUDIES

Protein size determination of mAb sample

Protein size determination of mAb sample

PROTEIN ANLAYSIS BY PAGE- CASE STUDIES

Aggregate analysis

PROTEIN ANALYSIS BY PAGE AT CBA

  PROTEIN ANALYSIS BY PAGE 
Sample requirement Amount- 1 ml (0.1-1 mg/ml)
Deliverables Gel Images (Staining by CBB) 
Information required from client
  • Approximate Mol. Wt of Protein
  • Buffer composition (in case of formulation)