When it comes to biopharmaceutical characterization, you need a partner with established expertise and resources. As a pioneer of physicochemical characterization, we offer you unrivaled expertise in protein, carbohydrate and nucleic acid analyses. Our laboratories pioneered the development of mass spectrometric methods for the structural evaluation of a range of biotechnology product types. Many of these have now become standard procedures worldwide.
Our protein analysis package encompasses the requirements of the ICH guidelines (particularly ICH Q6B), the U.S. FDA 'Points to Consider' documents and the concept of a 'well characterized' or 'specified' biological product.
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Individual methods and procedures, or the full protein analysis package, are available to GMP, including:
- Amino acid sequencing and analysis
- Extinction coefficient determination
- N- and C-terminal sequencing
- Peptide mapping
- Glycosylation analysis
- Spectroscopic profiles: CD, FTIR, fluorescence
- Aggregation analysis: SEC-MALS, SV-AUC, DLS, SEC-UV
- Inter and intra-molecular disulfide bridge analysis
- Molecular weight determination
- Electrophoretic profiles
- Qualitative and quantitative analysis of post-translational modifications
- Liquid chromatography: SEC, RP, HILIC and IEX
- Impurity identification
Similar characterization studies are also offered for carbohydrate biopolymers and conjugated molecules including:
- Composition analysis
- Molecular weight and heterogeneity assessment
- Sequence analysis
- Determination of antennary structure
- Linkage analysis
- Site occupancy for N, O and C-linked glycans
- Qualitative and quantitative sialic acid determination
- Determination of sulphated and phosphorylated glycans
We also offer a comprehensive range of techniques and procedures for nucleic acid-based biopharmaceuticals including:
- Molecular weight determination
- Sequence analysis
- Assessment of 5’ and 3’ structures and heterogeneity
- Location of modifications
- Impurity separation and identification
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134, Godo-cho, Hodogaya-ku,
Yokohama Business Park North Square I 5F, 240-0005,
Yokohama, Japan