Biosimilars/Biologics Drug Characterisation

Accredited Structural and Functional Characterisation

Delivering immediate, independent and affordable assistance in demonstrating biosimilarity, with data packs to meet FDA and ICH guidelines (ICH Q6B).

Biosimilar development begins with extensive structural and functional characterisation which underpins all further product development activities. Proteomics International operates a world leading ISO/IEC 17025:2005 accredited protein analysis laboratory, with a proven track record in characterising biosimilars.

ISO 17025 is the most widely used standard for USA Federal testing laboratories and shares the same objective as Good Laboratory Practice (GLP) to assure data quality.

The FDA states that the submission of a laboratory package from an ISO 17025 accredited facility will likely provide sufficient information for the purposes of their review.

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Projects successfully undertaken include:

• Insulin/Insulin lispro/Insulin glargine
• Epidermal growth factor (EGF)
• Rituximab (Zytux)/MabThera
• Ustekinumab (Stelara)
• Trastuzumab (Herceptin)
• Omalizumab
• Adalimumab
• Icatibant acetate
• Human growth hormone (HGH)
• Granulocyte-colony stimulating factor (G-CSF)
• Human follicle stimulating hormone (h-FSH)
• Recombinant coagulation factor VII
• Immunoglobulin (IgG) Fab fragment & whole molecule
• Eptifibatide (cyclic peptide)

Services include:

• Intact mass
• Peptide mapping for comprehensive protein sequence coverage
• Disulphide bridge analysis
• N-terminal and C-terminal protein sequencing by mass spectrometry
• Amino acid analysis including Cys determination
• Extinction coefficient determination
• Post-translational modifications including deamidation, oxidation and phosphorylation
• PEGylation analysis
• Stability testing and stress analyses
• Impurity profiling by SEC, IEF, HIC and WCX
• Fluorescence spectra analysis
• Glycomics/carbohydrate analyses including N- &  C-glycan analysis and monosacharide analysis
• AUC analysis
• CD analysis
• X-ray crystallography
• 1D SDS-PAGE

Project specific quotations will be provided upon request.
Request Form: Biosimilars | Biologics

Mass Spectrometry (MS) Analysis of Intact Proteins and Peptides

Suitable for pure samples, this service provides a molecular mass for the protein or peptide of interest.

Samples are processed intact (no enzyme digestion) using  LC/MS.

Request Form: Protein Mass Analysis

Disulphide Bridge Analysis

This technique is used to characterise disulphide folding pattern, ie an analysis of which Cys residues are linked.

Scope of work:

• Confirmation of protein by MS. Unambiguous identification is provided using our standard MS/MS sequencing service.
• Identification of location of disulphide bonds. Full protein characterisation will be performed using our high-end ESI-MS instruments. The analysis will look for disulphide bonded peptide fragments following enzyme digestion of the protein.

For analysis we require the full theoretical protein sequence, and postulated S-S bridging patterns.

Request Form: Disulphide Bridge Analysis

Peptide Mapping Analysis

A standard technique to confirm the amino acid sequence of a molecule, Peptide Mapping Analysis uses multiple enzyme digest strategy to break apart a protein into smaller peptide fragments which are subsequently analysed on the mass spectrometer.

Peptide fragments digested with different enzymes will highly likely provide overlapping amino acid sequence data, allowing for the accurate determination and confirmation of the amino acid sequence of the full length of a target protein molecule.

An added value of Peptide Mapping Analysis is that modifications such as C-terminal truncations and/or N-terminal modifications may also be detected.

For more information please email info@proteomics.com.au

N- & C-Terminal Analysis

Using mass spectrometry, we are able to determine a protein’s amino acid sequence at the N-terminus. Mass spectrometry can also be used to identify the amino acid sequence of N-terminally blocked proteins, where traditional N-terminal Edman sequencing fails.

Using our heavy water labeling strategy, we can determine the amino acids at a protein’s C-terminus. Using the correct enzyme during protein digestion in heavy water, we are able to confirm the protein’s C-terminus and any truncated forms.

For more information please email info@proteomics.com.au

Glycosylation

Comprehensive glycoprotein characterisation at the monosaccharride level is now available to complement existing detailed mapping of the amino acid sequence. Glycosylation analysis is ideal for Quality Control of Biosimilars, recombinant/fusion proteins and antibodies, and is a key component of the ICH Q6B guidelines for molecular characterisation.

For more information please email info@proteomics.com.au

Video:

Synergy between Australian industry and Indian pharmaceuticals

Dr Richard Lipscombe, Managing Director, shared his views and thoughts on the great union of the manufacturing skills present in India with the analytical skills we have in Australia… Watch