- Home
- Companies
- Proteomics International
- Services
- Proteomics - Biosimilars/Biologics Drug ...
Proteomics - Biosimilars/Biologics Drug Characterisation Services
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.
- 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)
- 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
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
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.