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Pharmaceuticals & Life sciences
We offer a wide rage of analytical services that can be utilized at any stage from pharmaceuticals and in vitro diagnostics to regulatory testing under GMP, GLP and reliability standards. We support to solve customers’ problems with our high-quality analytical services.
Topics
Customer’s Benefits
Imaging
Evaluation of distribution in tissue by Mass Imaging, Spectroscopic Imaging, Microscopic Imaging, etc.
Structural Analysis of medicines, Impurities and Decomposition
Evaluation of higher-order structures, Impurity analysis, Structure estimation
Intermolecular Interaction Analysis
Comprehensive interaction analysis by combining multiple methods (SPR, IPC, STD-NMR, Cross-Linked MS)
Analysis of Packages and Materials
Identification and quantification of eluates, Risk assessment (Extractable & Leachable Test), Morphological observation, Content analysis, Surface condition evaluation
Our services
Technical Documents
Imaging
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Quantitative Imaging of Trace Elements in Mouse Spinal Cord using fsLA-ICP-MS
Femtosecond (fs) LA-ICP-MS is a powerful technique for the trace element quantification in hydrous samples due to the under atmospheric pressure measurement. Moreover, isolated sampling and ionization processes, which eliminate the influence of coexisting component, are capable of high sensitivity and accuracy.
P02243_Quantitative_Imaging_of_Trace_Elements_in_Mouse_Spinal_Cord_using_fsLA-ICP-MS.pdf
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Visualization of molecular orientation in human hair -Using ATR FT-IR imaging-
ATR FT-IR imaging is a powerful tool for visualization of molecular orientation distribution as well as functional group distribution on sample surface. We investigated the difference in molecular orientation distribution on the longitudinal section of human hairs that were treated by two types of reducing agents.
P02188_Visualization_of_molecular_orientation_in_human_hair_Using_ATR_FT-IR_imaging.pdf
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Evaluation of medical materials degradation into several chemical agents -Using ATR FT-IR imaging-
The degradation and elution of plasticizer from several plastics by passing specific drugs through medical devices are well known. ATR FT-IR imaging is a powerful tool for visualization of effect from the surface of various samples. Polyvinyl chloride (PVC) and polycarbonate (PC) are common plastics used in medical devices. We investigated degree of effect from these plastics after dipping chemical solutions.
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The analysis of volatile components in anti-inflammatory tapes by means of Cryo-TOF-SIMS
Surface analysis methods generally need ultra high vacuum (UHV) condition. Therefore, it is impossible to analyze the samples including much volatile components which prevent exhaust of vacuum chamber (i.e. loadlock chamber). However, sample transferring system with cooling by liquid nitrogen enables the surface analysis for such samples.
P02089_The_analysis_of_volatile_components_in_anti-inflammatory_tapes_by_means_of_Cryo-TOF-SIMS.pdf
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Feature extraction from 2D TOF-SIMS data of biological samples by using multivariate analysis
TOF-SIMS data obtained from biological samples, whose composition is complicated, are generally huge and difficult to interpret. By using multivariate analysis (e.g. Principal Component Analysis: PCA), the features of original TOF-SIMS data can be extracted as easy-to-interpret data.
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Penetration evaluation of the chemical agent to the hair using NanoSIMS
NanoSIMS 50L possesses the highest lateral resolution among SIMS, as well as high mass resolution. Here, we introduce an example of penetration evaluation of the chemical agent as imaging of cross section of the hair penetrated by a stable isotope (deuterium) labelled compound.
P02074_Penetration_evaluation_of_the_chemical_agent_to_the_hair_using_NanoSIMS.pdf
Structural Analysis of medicines/Impurities/Decomposition
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Characterization of Antibody Drug with Ultra High Performance Mass Spectrometer
Toray Research Center has introduced an ultra high performance mass spectrometer for the first time as a CRO in Japan, and realized complete amino acid sequence and post-translational modification analysis of antibody drugs. It enabled us to conduct efficient deamidation analysis.
P02170_Characterization_of_Antibody_Drug_with_Ultra_High_Performance_Mass_Spectrometer.pdf
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Determination of N-terminal amino acid and C-terminal amino acid of degraded proteins
From the aspect of quality control of biopharmaceuticals, it is important to clarify impurities originated from main protein components. Here, we introduce a method to specify N-terminal and C-terminal amino acids of proteins degraded from main protein components.
P02125_Determination_of_N-terminal_amino_acid_and_C-terminal_amino_acid_of_degraded_proteins.pdf
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Analytical Technologies Accelerating the Research and Development of Oligonucleotide Therapeutics
In the R&D of oligonucleotide therapeutics, the analysis of impurities is essential for evaluating medicinal actions properly. The higher-order structure and complex formation of oligonucleotide therapeutics are important evaluation items because they probably have impacts on quality. The following are the examples of the nucleic acid analyses using ultra-high performance LC-MS, NMR, and CD.
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The Ultra-High Performance Mass Spectrometer Brings A New World of Modality Analysis
Toray Research Center has introduced an Ultra-High Performance Mass Spectrometer, for the first time as a contract research organization laboratory in Japan. The nano-LC installed on the front enabled us to perform high-resolution and high-sensitive analyses and to respond to increasingly diversified needs in modality analysis. We introduce some examples of our new methods.
P02005_The_Ultra-High_Performance_Mass_Spectrometer_Brings_A_New_World_of_Modality_Analysis.pdf
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Three-dimensional analysis of rat kidney tissue using X-ray CT and 3D-SEM
The kidney tissue of a rat is three-dimensionally observed by X-ray CT and 3D-SEM. Through imaging of tubules of a kidney and mitochondria in podocytes, we examined these techniques as three-dimensional analysis tools for biological sample.
P01897_Three-dimensional_analysis_of_rat_kidney_tissue__using_X-ray_CT_and_3D-SEM.pdf
Intermolecular Interaction Analysis
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Intermolecular Interaction Analysis (SPR, ITC)
In the R&D of drugs, diagnostic medicines, and others, interaction analysis of developing molecules and their targets is essential. Toray Research Center can evaluate the interaction analysis from various perspectives using our intermolecular interaction instruments such as ITC, NMR, MS and the latest SPR. The following are the features of SPR and ITC.
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ITC measurements of biomolecular interactions
Isothermal Titration Calorimetry (ITC) measures heat change during biomolecular binding, determining binding constants (Kd), stoichiometry (n), enthalpy (ΔH), and entropy (ΔS). The thermodynamic profile enables prediction of the binding from between biomolecules.
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Physicochemical Analysis of Intermolecular Interactions in Pharmaceutical and Diagnostics Research
The pharmacological action of drugs is induced and detection by diagnostics is conducted based on intermolecular interactions between bimolecular such as antibodies and antigen. Physicochemical analysis of intermolecular interactions enables molecular level evaluation of interactions, and is applicable to the optimization of the structure and function of drugs and diagnostics, as well as quality control.
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ITC measurement of biomolecular interactions
Isothermal Titration Calorimetry (ITC) measures heat transfer during biomolecular binding, determining binding constants (Kd), reaction stoichiometry (n), enthalpy (ΔH), and entropy (ΔS). The thermodynamic profile enables determination of binding form between biomolecules (specific or non-specific binding).
Analysis of Packages and Materials
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Extractable & Leachable Test
Migratable compounds from the components of medical products, so called "Extractable & Leachable", are critical for the safety of users. Analytical expertise and experience for the industrial materials are necessary for detection and determination of the chemical compounds. Additionally, biological or toxic risk assessment of each compound is inevitable. Toray Research Center provide sophisticated E & L Test services based on the long-term experience in the industrial and pharmaceutical analysis.
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HR-MS of solvent extracts at 1mmφ spatial resolution - Elution Profile based on Solvent Polarity, Analyte Region -
LESA (Liquid Extract Surface Analysis) nano ESI-MS systems capable of surface analysis under atmospheric pressure can solvent-extract surfaces at 1mmφ spatial resolution to assign the structure of eluted molecules from materials by HR (High Resolution)-MS. Extraction and direct analysis can rapidly provide information on various solvents in each area.
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Analysis for Organ-on-Chips Materials
MPS (Micro Physiological System) represented by Organ-on-Chips is one of the latest pharmacokinetic evaluation tools that combines cells and materials, and it is necessary to select and design optimal materials to reproduce the desired organ function.
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Composition analysis of UV curable adhesive
Industrial materials is generally a mixture composed of multiple components. Although it is important to know chemical structure of the components for understanding material characteristics, it is not that simple to qualify the components because there are wide variety of chemical compounds with chemical structure, molecular weight, polarity, etc. in organic materials. We can clarify the composition of such a UV curable adhesive by high level separation techniques and appropriate analytical methods to determine unknown chemicals in details.
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Quantitative analysis of Si by means of ICP-OES
Inductively coupled plasma-optical emission spectrometry (ICP-OES) is widely used for precise inorganic component analysis. The method for decomposition of analytes with chemicals is an important factor affecting analytical results, especially for Si.
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Outgas analysis of the olefin-based polymer under gamma beam irradiation
Various troubles about a resin product (e.g. breaking, transformation, change of color, odor) may be caused under gamma beam irradiation. For these problems, outgas analysis is effective.
P01660_Outgas_analysis_of_the_olefin-based_polymer_under_gamma_beam_irradiation.pdf
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Investigation of the Effect of γ-irradiation on Physical Properties of Cyclo-Olefin Polymer (COP)
γ-irradiation is frequently used for sterilization of medical-care equipment. We investigated the effect of γ-irradiation on physical properties of cyclo-olefin polymer (COP). As a result, it was revealed that the oxidation and the formation of network structure such as cross-linkage occurred at the surface of COP by γ-irradiation.