Pharmaceutical

GC/MS Analysis under GMP - Highly Sensitive Analysis for Impurities in Nucleic Acids -
In the quality test of nucleic acid medicines, plenty of samples can not be used for analysis, unlike the case of small molecule drugs. Especially in the analysis for impurities, highly sensitive analysis is need to perform the test using limited amount of valuable samples. In this report, the residual solvents contained in a commercially available nucleic acid sample were measured by highly sensitive headspace-GC/MS. TechData_P01998E (PDF:313KB)
Determination of Residual Solvents in Drugs by Ion Chromatography
Residual solvents in pharmaceutical products are to be determined in the process of the drug approval application. We have developed analytical methods by ion chromatography (IC) for determining ionic compounds and organic acids, which are not suitable analytes for the general gas chromatography (GC) method. TechData_P01663E (PDF:305KB)
Characterization of Liposome Drug Products
The liposome drug product is one of the innovative pharmaceuticals. As encapsulated substances in liposome are selectively delivered to its target site, the effectiveness and stability of the drug in vivo are expected to be improved. According to the guidelines for the development of liposome drug products, we have investigated the particle size distribution, surface charge, phase transition temperature, morphology, and structure. TechData_P01800E (PDF:744KB)
Structural Analysis of Nucleic Acids by CD and NMR
Higher-order structure of nucleic acids varies depending on the base sequence, salt concentration and temperature. CD (circular dichroism) and NMR (nuclear magnetic resonance) are commonly used for the evaluation of higher-order structure of nucleic acids. The following are examples of structural analysis of nucleic acids using the CD and NMR. TechData_P01862E (PDF:580KB)
Hybrid fluorescence / TOF-SIMS imaging of bio-samples using noble probe immunostaining method
TRC synthesize a noble probe which is both compatible for fluorescence and TOF-SIMS analysis. Combining with an immunostaining method, we perform hybrid fluorescence/TOF-SIMS imaging of antigen proteins in mouse nerve fibers in a quantitative manner. TechData_P01908E (PDF:524KB)
Surface imaging of bio-samples using immunostaining-NanoSIMS
NanoSIMS 50L possesses the highest lateral resolution among SIMS, as well as high mass resolution at the same time. TRC achieved NanoSIMS imaging of proteins in bio-samples with a newly synthesized probe combined to antibody. TechData_P01912E (PDF:1,431KB)
LC/MS/MS methods for optical resolution and quantification of D- and L-amino acids
D-amino acids research has been progressing rapidly in the fields of pharmaceutical, medical, and other life science as well as food, drink, health and cosmetics. TRC has launched new contract service using LC/MS/MS. After pre-column derivatization of amino acids, D- and L- amino acids are resolved optically and quantified simultaneously with ultra-high sensitivity. TechData_P01803E (PDF:436KB)
TOF-SIMS Imaging of Mouse Cerebellar Tissue
Mass spectrometry (MS) imaging has attracted interest as a method of directly visualizing the substances present in tissue. Recent years has seen increasing use of investigations based on MALDI-TOF-MS and TOF-SIMS. Here, we present examples of MS imaging of tissue sections using TOF-SIMS, which is inferior to MALDI-TOF-MS in terms of sensitivity in the high-mass range but achieves superior spatial resolution. TechData_P01093E (PDF:2,162KB)
High sensitive elemental imaging of polymer and biological material by LA-ICP-MS
Laser Ablation Inductively Coupled Plasma Mass Spectrometry (LA-ICP-MS) gives us information on trace-level metal with higher sensitivity than other methods. Furthermore, elemental imaging is available for the cross section of biological material as well as polymers. TechData_P01590E (PDF:851KB)
Aggregation Analysis of Biotherapeutics By Analytical Ultracentrifugation - comparison between AUC and DLS -
Recently, the need for aggregation analysis of biotherapeutics has increased. Analytical ultra-centrifugation (AUC) has attracted attention as one of the effective methods. We measured aggregates of biopharmaceuticals by AUC and Dynamic light scattering (DLS), and compared both methods. TechData_P01541E (PDF:232KB)
Deep Proteomics
Here we demonstrate a new LC-MS/MS analysis method for peptide mixtures with high resolution by combining ion exchange chromatography and C18 long monolith column chromatography. Analysis of standard cultured cells resulted that more than 6000 proteins were identified at a quantifiable level. TechData_P01798E (PDF:396KB)
Measurement of number of low molecular weight compounds labeled to proteins
In the field of diagnosis, etc., it is often required to evaluate how many compounds are covalently labeled per molecule of the protein. Here we introduce examples of how many FITC dyes were labeled in the antibody. This measurement is also applied to analysis of antibody-drug conjugates (ADCs). TechData_P01766E (PDF:501KB)
Cell-based assay - Luciferase reporter bioassay -
ADCC luciferase reporter bioassay is bioluminescence test for antibody-dependent cell-mediated cytotoxicity. This assay shows ADCC activity with luminescence intensity. With excellent reproducibility, this assay is helpful for quality assurance, bioequivalence study, and neutralization assay for antibody drugs. TechData_P01653E (PDF:373KB)
Development of anti-drug antibodies assay (Ligand Binding Assay)
Anti-drug antibodies (ADA) assay is crucial to application for biopharmaceuticals including antibody drugs. TRC offers a series of services to prepare critical reagents for ADA bridging assay, develop and validate the assay method, and conduct study sample analysis. TechData_P01516E (PDF:520KB)
Peptide Synthesis-Synthesis of Peptide Analogs-
Our peptide synthesis / High quality (high purity) & fast turn around / Technology to produce peptides ≥ 100 residues / A variety of site-selective modifications TechData_P01648E (PDF:254KB)
Structural analysis of peptide trace decompositions
Peptides, middle-size molecules, are big hope as one of next-generation drugs. The structural analysis of the decomposition and impurities is critical to ensuring stable quality. TRC possesses technologies for small molecule drugs, ranging from fractionation and structural analysis of trace components of APIs and drug products, and peptide synthesis technologies. Here is an example of our structural analysis of Ghrelin(1-8) trace decomposition using MS and NMR. TechData_P01745E (PDF:489KB)
ITC measurement of biomolecular interactions
Isothermal Titration Calorimetry (ITC) measures heat transfer during biomolecular binding, determining binding constants (Kd), reaction stoichiometry (n), enthalpy (∆H), and entropy (ΔS). The thermodynamic profile enables determination of binding form between biomolecules (specific or non-specific binding). TechData_P01797E (PDF:389KB)
Imaging with Raman spectroscopy-Distribution of ingredients in medicinal tablets-
Imaging with Raman spectroscopy is sensitive and is the method which can estimate the ingredient distribution by high spatial resolution. Therefore, it is powerful technique possible about detecting the distribution of medicinal properties, its crystal polymorph and additive. TechData_P01129E (PDF:883KB)
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. 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. TechData_P02074E (PDF:397KB)
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. TechData_P02005E (PDF:438KB)
Impurity Analysis in API and Drug Product Using Orbitrap –Quantitation of N-Nitrosodimethylamine(NDMA)–
N-Nitrosodimethylamine (NDMA) is known as a carcinogenic substance. The NDMA can be generated in the manufacturing process of API (active pharmaceutical ingredients) or drug product under the existence of nitrous acid, if the structure has a dimethylaminomethyl group. The authorities specify an allowable NDMA intake amount, and it is very important to evaluate the NDMA content in API /drug product. TechData_P02076E (PDF:223KB)
Latest IR spectroscopy with sub-micron spatial resolution
Optical Photothermal IR Spectroscopy (O-PTIR) enables the infrared measurement with a high spatial resolution of less than 1 μm. It can be applied to analyze the composition of small foreign substances, the interface composition of multi-layered samples, and even water containing sample. TechData_P01951E (PDF:254KB)