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  6. Safety testing of recombinant proteins and monoclonal antibodies.

Safety testing of recombinant proteins and monoclonal antibodies.

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last updated:Apr 27, 2016

メディリッジ
メディリッジ
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Rich experience and accumulated achievements! Reliable technology, trusted biopharmaceutical safety testing.

MediLidge Co., Ltd. provides a wide range of services from non-clinical trials for recombinant protein production and monoclonal antibody manufacturing to clinical sample analysis. Using new equipment and reliable technology, we conduct tests in compliance with GLP for the following items: 【Main Test Items】 ■ Validation of virus clearance ■ Custom host protein measurement ■ Bioassays and potency tests using cells ■ Lot release testing ■ Binding quantification methods and immunological measurement methods, etc. *For more details, please refer to our catalog or feel free to contact us.

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Safety testing of recombinant proteins and monoclonal antibodies.

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【Service Contents】 ■ Validation of Virus Clearance - Cytotoxicity Testing - Addition Recovery Testing - Virus Interference Testing ■ Custom Host Protein Measurement - Method Development - Method Optimization - Method Validation ■ Bioassays and Potency Testing Using Cells - Method Development - Method Optimization - Method Validation ■ Lot Release Testing - Residual Host DNA - Residual Host Protein ■ Binding Quantification Methods and Immunological Measurement Methods - Development and Validation of Pharmacokinetic (PK) Methods - Development and Validation of Toxicokinetics (TK) Methods - Development and Validation of Antibody (ADA) Methods Due to Drug Immunogenicity - Biomarker Measurement - Receptor Binding Testing ■ Support for Non-Clinical and Clinical Trials - Sample Analysis for Pharmacokinetics (PK) - Sample Analysis for Toxicokinetics (TK) - Testing and Sample Analysis for Antibody (ADA) Due to Drug Immunogenicity ■ Others *For more details, please refer to the catalog or feel free to contact us.

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Safety testing of recombinant proteins and monoclonal antibodies.

Safety testing of recombinant proteins and monoclonal antibodies.

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Leveraging my experience in university work and research and development at a major diagnostic reagent company, as well as my experience in contract business, I aim to provide contract services that meet customer needs with a motto of <quality, speed, and reasonable prices> while collaborating with various locations. For those looking to enter the field of research reagents or diagnostic reagents, I am here as a friendly consultant to respond to your requests for consulting, contract services, and outsourcing, so please feel free to reach out.

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