Comparability Studies

Detailed comparability studies covering the physicochemical, structure and biologic potency characterization of a range of biosimilars and biopharmaceuticals

Comparability studies are of major importance in the development of biosimilars and biopharmaceuticals. These studies are key to the development of biosimilars, which is a process that is chiefly concerned with the comparability of the biosimilar to the originator drug product – this relies on detailed analytics. For innovative products, these studies demonstrate comparability which may be required to qualify sources of clinical trial materials following process development, optimization, and scale-up.

Based on many years of experience, Intertek offers a strategic approach to biosimilar analytical programs that provide highly relevant early stage characterisation and later stage comparative data. These programs evaluate and compare all pertinent features of the biosimilar product and are based on the criteria outlined in ICH Q6B. Programs encompass many different analytical techniques and provide information ranging from evaluation of physiochemical properties and structural features including primary, secondary and higher order structure and assessment of post-translational modifications (PTM) to determination of biological potency and assessment of purity / impurity profiles.

We are highly experienced in comparability studies conducted to Good Laboratory Practice (GLP) or Good Manufacturing Practice (cGMP) standards for biosimilars, monoclonal antibodies and recombinant proteins.

Biologics comparability services include:

cGMP Cell-based Bioassays

Protein physicochemical properties

  • Molecular weight by mass spectrometry (MALDI-MS, electrospray MS and LCMS) 
  • Isoform and impurity studies using electrophoresis and chromatography methods (PAGE, SDS-PAGE, IEF, CE, HPLC)
  • Extinction coefficient determination and validation

Protein structure analysis

  • Amino acid sequence (broad range of digestion and LC-MSMS strategies)
  • Amino acid composition by chromatographic techniques (ion chromatography (IC), HPLC, UPLC)
  • Peptide mapping by protease digestion followed by mass spectrometry approaches (LC-MS, LC-MS/MS and MALDI-MS). This typically also provides the N– and C– terminal sequence information.
  • Disulphide bridge mapping using protease digest and chemical modification experiments followed by MALDI-MS
  • Free thiol determination
  • Carbohydrate structure including enzymatic glycan cleavage and MALDI-MS, chromatography
  • Glycosylation detection/fingerprinting
  • Characterization of Post Translational Modifications (PTMs) i.e.deamidation, acetylation, phosphorylation and more

Liquid chromatographic patterns

  • Reverse phase high performance liquid chromatography (RP-HPLC), ion exchange HPLC and size exclusion chromatography (SEC)

Spectroscopic profiles

 
Need help or have a question? +1-858-558-2599
 

Need help or have a question?

+1-858-558-2599
EMEA UK:
+44 161 721 5247