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A range of accredited and proven QC proteomics services that will assist you in demonstrating biosimilarity to a reference protein product. Our laboratory will use a set of analytical procedures to comprehensively characterize proteins and polypeptides to meet ICH guidelines (ICHQ6B).
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Accredited QC Testing
Biosimilars, biologics and follow-on therapeutics
ISO 17025
Technical excellence
Accredited proteomics laboratory
Data analysis is undertaken to ISO/IEC 17025:2005 laboratory standard, the world's main standard used by testing and calibration laboratories. Proteomics International has offered protein analysis services since 2001 and in 2009 became the world's "rst facility to receive ISO 17025 accreditation for its for proteomics services. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of technical competence to the equation.
ISO 17025 ensures laboratories generate technically valid results, and is the most widely used laboratory standard for US Federal testing laboratories.
About the company
Proteomics International is a privately operating company based
in Australia and has established itself as a world leader in the delivery of
contract research analytical services, particularly in the areas of biosimilars,
biologics and follow on therapeutics.
The company has been operational for 11 years and has a team of 20 including highly quali!ed and
experienced protein and peptide scientists.
Proteomics International is also a research and development company focusing on developing value
speci!cally from protein based biologicals research, drug discovery and biomarker validation. The company has
developed novel, highly effective tools in these areas, which are now applied to enhance its analytical capabilities.
Australian headquartersPerth, Western Australia
The laboratory houses a full suite of analysis equipment that delivers greater performance and sensitivity, higher confidence of results and reproducibility and a more comprehensive in-depth identification and relative quantitation of proteins in complex samples.
‣ 5800 MALDI TOF-TOF ultra-high throughput ms
‣ 5600 Quad-TOF ms for sensitivity and precision
‣ 4000 Q-Trap analytical ms (LC/MS/MS)
‣ Prominence nano LC
‣ Nexera UHPLC
‣ Ultimate 3000 nano 2D LC system
‣ Probot micro spotter
The most advanced instrumentation available
Satisfy regulatory requirements
Accredited QC services that characterises biosimilars, biologics and follow-on therapeutics with precision to meet ICH guidelines (ICH Q6B).
‣ Protein sequence mapping by MS/MS Comprehensive amino acid sequence coverage is obtained by multi-enzyme digest strategies, coupled with multi-instrument approaches. Data analysis incorporates the latest algorithms and includes options for de novo sequencing.
‣ Di-sulphide mapping Characterising disulphide folding patterns to confirm correct or misaligned bridges, and free or capped cysteine residues. A number of specialist and best-in-class techniques are applied.
‣ Glycosylation analysis Comprehensive glycoprotein characterisation at the monosaccharride level complements existing detailed mapping of the amino acid sequence.
‣ PEGylation analysis Determination of major and minor PEG binding positions, including relative amounts attached to each site.
‣ N-terminal (Edman) and C-terminal sequencing Identification of the amino-and carboxy-terminal amino acids to confirm sequence and homogeneity.
‣ Intact mass determination Precise, absolute mass measurement using mass spectrometry.
‣ Impurity profiling Techniques used include nano HPLC, UPLC and Multiple/Selective reaction monitoring to provide sensitivity and highly specific measurements to detect and quantify compounds such as truncated fragments, deamidation and oxidation.
‣ Aggregation analysis by analytical ultracentrifugation
‣ Circular dichroism, NMR & X-ray
‣ Amino acid analysis and more
Comprehensive analysis
Proven biosimilars track record
‣ Epidermal growth factor (EGF)
‣ Follicle stimulating hormone (h-FSH)
‣ Granulocyte colony-stimulating factor (GCSF)
‣ Human growth hormone (HGH)
‣ Insulin
‣ Immunoglobulin (IgG) Fab fragment
‣ Immunoglobulin (IgG) whole molecule
‣ Eptifibatide (cyclic peptide)
‣ Octreotide (cyclic peptide)
Proteomics International has attracted and maintained an array of blue chip international clients. The company has successfully undertaken many biosimilars projects including, but not limited to:
Data packages have been used for regulatory submission in the USA, Europe, India and China
Proteomics International Pty Ltd
Australian Business Number 78 096 013 455
ISO/IEC 17025 NATA Accreditation Number 16838
www.Proteomics.com.au
ICH guidelines (ICH Q6B) require that the proteins and polypeptides are comprehensively characterised using an appropriate set of analytical procedures
Proteomics International Pty [email protected] + 61 8 9389 1992Facsimile + 61 8 9389 1981
1st Base Pte [email protected] + 65 6775 7318Facsimile + 65 6775 7211
Singapore
First BASE Laboratories Sdn [email protected] + 603 8943 3252Facsimile + 603 8943 3243
Malaysia / Indonesia India
KAN-THT (India) Pvt [email protected] + 91 11 47010775Facsimile + 91 11 470 10779
Hong Kong | China
Asia Bio Channel Limitedwww.asiabiochannel.combcoissac@asiabiochannel.comTelephone +852 9845 4791
Australia and other countriesJapan
Leave a Nest Co. [email protected] +81 3 6277 8041Facsimile +81 3 6277 8042
Accredited QC TestingISO 17025
