Comparability Studies for Biopharmaceuticals
We are highly experienced in the biophysical characterization of a diverse range of biopharmaceuticals, and have conducted detailed GLP or 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 to demonstrate comparability 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. A comparability study is also key to the development of biosimilars.
Our services include:
- Molecular weight by MALDI-MS, electrospray MS and LCMS
- Amino acid composition
- Peptide mapping 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 behavior of samples when stressed by heating, resulting in loss of secondary/tertiary structure and precipitation
- Fluorescence Studies
Quarternary Structure and Aggregation State
- SEC-MALLS and DLS studies
- Imaging of aggregates using electron microscopy following immuno-gold labeling
- Fluorescence studies of behavior under denaturing conditions e.g. heat or urea
(*CD data is generated in conjunction with partner laboratories and we include QA audits for formal regulatory studies)
Related Services
Request more information to see how Intertek can help your organization with Comparability Studies for Biopharmaceuticals.