Biopharmaceutical Structural Characterisation

Biopharmaceuticals can present significant analytical challenges to the development path of a new product. Intertek Pharmaceutical Services is highly experienced in providing comprehensive biophysical characterization services for biopharmaceuticals.

Structural Characterisation and Confirmation:

• Isoform and impurity studies using e.g. PAGE, SDS-PAGE, IEF, CE, HPLC

• Amino acid composition by e.g. ion chromatography

• Peptide and disulphide bridge maps by using MALDI or electrospray MS

• N and C-Terminal sequences e.g. by LCMSMS sequencing of peptide fragments from digests containing N and C termini

• Sequencing and post translational modification studies using a broad range of digest strategies and

• LCMSMS (including enhanced scan techniques)

• Studies of conjugated products (e.g. protein-toxin conjugates) using LCMS / LCMSMS to determine loading and binding sites

• Glycosylation studies by enzymatic glycan cleavage and fingerprinting by IC or MALDI-MS

• Advanced glycosylation studies using multiple cycles of selective enzymatic cleavage and MALDI-MS to build up a detailed picture of branching etc

• Viral proteome studies to support the characterisation of viral products used in vaccine and gene therapy products

• Basic activity assays e.g. sandwich ELISA, Western-Blot
  

Higher Order Structural Characterisation:

• Circular dichroism studies (via partner organisation*) to generate information on secondary structural features (α-helix, β-sheet, β-turns)

• High field NMR studies e.g. 2D NOESY (through space correlation) and TOCSY (through bond) correlation experiments

• FTIR studies with deconvolution of the amide-1 band to provide estimates of secondary structural features

These services are available as components of comprehensive comparability studies. Intertek's comparabilities studies are available as formal regulatory studies.

Biopharmaceutical Services include:

• Structural Characterisation and Confirmation

• Method Development and Validation

• Higher Order Structural Characterisation

• Aggregation State Characterisation

• Isolation and Characterisation of Product Related Impurities

• Process Impurity Method Development, Validation and QC

• Comparability Studies

• Specialist Services for Antibody Therapeutics