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  6. [Presentation of Materials] Contract Development and GMP Contract Manufacturing of Biopharmaceuticals

[Presentation of Materials] Contract Development and GMP Contract Manufacturing of Biopharmaceuticals

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[Exhibition Participation] Bio Pharmaceutical EXPO Participation! July 9 (Wed) - 11 (Fri), 2025 @ Tokyo Big Sight East Hall 7 E12-38

last updated:Jun 18, 2025

リブラメディシーナ
リブラメディシーナ
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By achieving consistent DS and DP manufacturing within the same facility, the need for multiple contract management, material transportation, and technology transfer is minimized! [Exhibiting at BioPharma Expo]

We are the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for biopharmaceuticals from Mycenax Biotech Inc. We offer contract research and manufacturing services for monoclonal antibodies (mAb), bispecific and multispecific antibodies, antibody-drug conjugates (ADC), enzymes, recombinant proteins, cell therapy products, and plasmid DNA. All manufacturing operations comply with PIC/S GMP standards and meet international regulations. By integrating LIMS and QMS, we achieve an efficient and high-quality manufacturing system. 【Features】 ■ Quality system compliant with GMP and with a track record of regulatory inspections ■ Consistent manufacturing of active pharmaceutical ingredients (DS) and formulations (DP) at the same facility, reducing costs and risks ■ Equipped with dedicated manufacturing facilities that accommodate CHO cells, E. coli, human cell lines, and high-potency formulations \ For more details, please check "Download Catalog" /

    Contract manufacturingVarious recombination contractsOther Contract Life Science Specialization
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[Presentation of Materials] Contract Development and GMP Contract Manufacturing of Biopharmaceuticals

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  • Related Link - https://www.lmed.co.jp/

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【Bio Pharmaceutical EXPO Exhibition Information】 Date: July 9 (Wed) - 11 (Fri), 2025, 10:00 AM - 5:00 PM Venue: Tokyo Big Sight Booth Number: East Hall 7 E12-38 Register for attendance here↓↓ https://www.interphex.jp/tokyo/ja-jp/register.html?code=1358635194288810-TSG *For more details, please download the catalog or feel free to contact us.

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【Uses】 ■ Maintain a cost-competitive development and production system, such as developing high-productivity cell lines in a short period. ■ Supply multiple formulations for both commercial production (in-house developed products) and for early and late-stage clinical trials. ■ Batch sizes accommodate from 1,000 to 100,000 vials. ■ Robust quality control system. ■ Implement operations compliant with PIC/S GMP and conforming to international regulations. ■ Integrate LIMS (Laboratory Information Management System) and QMS (Quality Management System) to enhance the efficiency of quality control and assurance. ■ Provide quick and cost-effective solutions. *For more details, please download the catalog or feel free to contact us.

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Contract development and GMP contract manufacturing of biopharmaceuticals (MYCENAX Company Introduction)

Contract development and GMP contract manufacturing of biopharmaceuticals (MYCENAX Company Introduction)

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Contracted Service "Clinical Trial Services"

Contracted Service "Clinical Trial Services"

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Libra Medicine's partner company, Mycenax Biotech Inc., has received conformity approval from the European Medicines Agency (EMA).

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Our partner company, Mycenax, conducted an on-site inspection by the EMA (in January 2025) and received formal periodic synthesis approval notification in March 2025. As a result, we have completed inspections by regulatory authorities in Japan, Canada, and Europe over the last two quarters and received official "pass" notifications. 【Health Canada】 (October 2024) – Conducted a 5-day on-site inspection, completed one day ahead of schedule. Received formal "pass" notification in December 2024. 【PMDA】 (November 2024) – Conducted a 4-day on-site inspection, completed half a day ahead of schedule. Received formal "pass" notification in February 2025. 【EMA】 (January 2025) – Conducted a 10-day on-site inspection, completed two days ahead of schedule. Received formal "pass" notification in March 2025. The fact that these inspections were completed earlier than initially planned indicates that Mycenax's manufacturing facilities and quality management systems are highly regarded by international regulatory authorities.

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リブラメディシーナ

リブラメディシーナ

Pharmaceuticals and Biotechnology

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Libra Medicina Co., Ltd. aims to contribute to the improvement of health and quality of life for people around the world by being involved in the creation of innovative pharmaceuticals and medical devices through development support services and licensing activities, delivering hope to patients suffering from serious diseases.

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