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Profile
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Delegates :
Ayano Fukuhara |
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Incorporated :
August 1 , 2006 |
Paid in Capital :
5 Million yen |
Employees :
6 人 |
Address :
502 Photonics Center, Osaka University 2-1 Yamadaoka, Suita OSAKA
〒565-0871
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TEL/FAX :
+81-6-6155-7835 / |
URL：
http://u-medico.co.jp/ |
Attachment :
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Mission/Background :
U-Medico is a venture contract research organization (CRO) originating from Osaka University. With a key focus on physicochemical analysis of biopharmaceuticals, U-Medico provides a full range of world-class formulation development services and stability testing, both non-GMP and reliability assurance level, for pharmaceutical customers using cutting-edge analytical techniques. Extensive experience enables U-Medico to provide expert consultancy services in the field of biopharmaceutical manufacturing. |
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Technology & Business
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We provide a broad range of services for physicochemical characterization of biopharmaceuticals to support all aspects of formulation development. For the most accurate characterization of aggregates in the nanometer to micrometer range, we apply multiple techniques including analytical ultracentrifugation and flow imaging. By using novel mass spectrometry (MS) techniques, such as hydrogen/deuterium exchange and native MS, we provide structural analysis for identification of the protein-protein interaction site, monitoring conformational changes, and for comparative analysis of the higher-order structure of biosimilars. In addition to non-GMP, we offer reliability assurance services, providing data that can be used in drug applications. Partnership with an accomplished Europe-based CRO enables us to address even the most challenging formulation development tasks, such as lyophilization and large-scale stability testing. We also offer a wide range of consulting services for biopharmaceutical manufacturing.
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Products & Service
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Products & Service Name
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Stage
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Outline
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Milestone
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Aggregation analysis of biopharmaceuticals
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Service/Marketing
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Quantification of biopharmaceutical aggregates in the nanometer-millimeter size ranges using multiple techniques
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Expanding of the contract service
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Structural analysis of biopharmaceuticals
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Service/Marketing
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Identification of protein-protein interaction sites, monitoring of conformational changes, biosimilar comparability studies
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Expanding of the contract service
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Formulation development of biopharmaceuticals
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Service/Marketing
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Development of stable protein formulations through evaluation of colloidal and structural stability, formulation screening
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Expanding of the contract service
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Stability testing of biopharmaceuticals
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Service/Marketing
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Biopharmaceutical stability testing based on ICH guidelines, physicochemical analysis at different time points
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Expanding of the contract service
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Biopharmaceutical consulting services
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Service/Marketing
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Consulting services in the field of biopharmaceutical manufacturing spanning the whole product development cycle
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Expanding a range of consulting services
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Highlights
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With 11 years of experience and more than 30 domestic and international customers, we have a proven track record of delivering high-quality tailored solutions for our customers’ needs. For pharmaceutical manufacturers, we provide strong support in formulation development and stability studies. To serve the needs of our chemical and material manufacturing customers, we routinely perform particle size analysis of synthetic polymers and other macromolecules.
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Hot news
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We have started collaboration with Coriolis Pharma, a Germany-based independent, privately owned contract research organization, having an extensive experience in providing premium analytical services to the pharmaceutical industry. This strategic partnership enables us to provide all cutting-edge analytical services for biopharmaceutical development.
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Alliance strategy
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We offer cooperation to biopharmaceutical manufacturing companies, which do not have in-house expertise.
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