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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Project specific quotations will be provided upon request:
Biosimilars | Biologics
Suitable for pure samples, this service provides a molecular mass for the protein or peptide of interest.
Samples are processed intact (no enzyme digestion). Depending on the size of the molecule and mass accuracy required MALDI-TOF MS and/orLC/MS is used.
For a RMM <6000amu MALDI-TOF is recommended, and >6000amu LC/MS is preferred.
Request Form: Protein Mass Analysis
This technique is used to characterise disulphide folding pattern, ie an analysis of which Cys residues are linked.
For analysis we require the full theoretical protein sequence, and postulated S-S bridging patterns.
Request Form: Disulphide Bridge Analysis
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.
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