Intertek (www.intertek.com)
 

Comparability Studies for Biopharmaceuticals

Industries serviced: Medical & Pharmaceutical

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EMEA UK:+44 161 721 5247

We are highly experienced in the biophysical characterization of a diverse range of biopharmaceuticals, and has conducted detailed GLP/cGMP comparability studies for product structure and impurity characterization.

Comparability studies are of major importance in the development of biopharmaceuticals. For new products, these studies may be required to qualify sources of clinical trial materials following process development, optimization, and scale up as progress through the clinical development phases is made.  The demonstration of equivalence to materials used in toxicology and early phase clinical trials is necessary to avoid bridging studies which clearly can add significant timescales and cost to drug development . Comparability studies are also key to the development of biosimilars.  Our services include:

Primary Structure

  • Molecular weight by MALDI-MS, electrospray MS and LCMS
  • Amino acid composition
  • Peptide mappng by protease digestion followed by LCMS, LC-MS/MS and MALDI-MS (this typically also provides the N– and C– terminal sequence information)

Post Translational Modifications

  • Disulphide bridge mapping using protease digest and chemical modification experiments followed by MALDI-MS
  • Free thiol determination
  • Glycosylation detection/fingerprinting using acid hydrolysis followed by anion exchange chromatography with electrochemical detection
  • Characterization of other PTMs i.e.deamidation, acetylation, phosphorylation

Chromatographic Profiles

  • Profiles generated using LCMS, reducing and non-reducing gel electrophoresis, horizontal and vertical gel isoelectric focusing and capillary isoelectric focusing

Secondary and Tertiary Structure

  • Determination of secondary structural attributes (α-helix, β-sheet, β-turns) using FTIR and circular dichroism (CD)*
  • NMR studies using 500 MHz instruments to compare the behaviour of samples when stressed by heating, resulting in loss of secondary/tertiary structure and precipitation

Quarternary Structure and Aggregation State

  • SEC-MALLS and Analytical Ultra Centrifugation (AUC*) studies
  • Imaging of aggregates using electron microscopy following immuno-gold labeling
  • Fluorescence studies of behavior under denaturing conditions e.g. heat or urea

(*CD and AUC data are generated in conjunction with partner laboratories and we include QA audits for formal regulatory studies)

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