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Biological Product
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Flow Cytometry and qPCR under GMP
We have introduced flow cytometer and qPCR in order to analyze cell therapy and gene therapy products. In preparation for regulatory submission, we are operating these instruments under Good Manufacturing Practice (GMP). Here we show some examples of these analyses.
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SEC-MALS Analysis under GMP － Molecular Weight Determination of Aggregates －
Evaluation of aggregates is indispensable for the quality test of antibody drugs. Absolute molecular weight distribution, mean absolute molecular weight, and radius of gyration of macromolecules are determined by SEC-MALS without constructing a calibration curve. In this report, aggregates were prepared by heating the human IgG antibody, and the molecular weight of the aggregates was determined by SEC-MALS.
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Analysis of Residual Free Polyethylene Glycol and Additives Contained in Biopharmaceuticals Using a Charged Aerosol Detector
The charged aerosol detector (CAD) can detect the compounds that have no absorption on ultraviolet rays. Since the sensitivity of the detector depends on the weight concentration of the analyte concerned, the detected peak responses can be directly compared among different compounds. Using CAD, we analyzed residual free polyethylene glycol (PEG) and additive polysorbate, monitoring of which is needed in the development of modified biopharmaceuticals.
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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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.
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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 (∆H), and entropy (ΔS). The thermodynamic profile enables determination of binding form between biomolecules (specific or non-specific binding).