Contract services for the development and manufacturing of monoclonal antibody (mAb) pharmaceuticals.
Implementing LIMS (Laboratory Information Management System) and QMS (Quality Management System)!
We would like to introduce the monoclonal antibodies (mAb) provided by Mycenax Biotech Inc., as well as our contract development and manufacturing services for cell and gene therapy pharmaceuticals. The company is a biopharmaceutical CDMO with many years of experience, offering comprehensive development and manufacturing solutions. We can accommodate small-scale manufacturing for clinical trials, as well as large-scale manufacturing for commercial production (50L to 2,000L), and we are capable of aseptic filling (vials [liquid and lyophilized], pre-filled syringes [PFS], cartridges). 【Features】 ■ Operations compliant with PIC/S GMP, conforming to international regulations, with a track record of regulatory inspections ■ Consistent DS/DP manufacturing within the same facility minimizes the need for multiple contract management, material transportation, and technology transfer ■ We have multiple dedicated manufacturing facilities, including those for CHO, E. coli, human cell lines, and high-potency formulations, supporting the development and manufacturing of complex biopharmaceuticals *For more details, please download the PDF (English version) or feel free to contact us.
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basic information
**Main Capabilities of Mycenax** - End-to-end biopharmaceutical development and manufacturing - Full-service offerings from Proof-of-Concept and manufacturing suitability testing to toxicity testing, clinical trials, and commercial production - Contract development and manufacturing services for pharmaceuticals, including dual/multiple specificity antibodies, enzymes, recombinant proteins, cell and gene therapies, and plasmid DNA - Flexible DS (Drug Substance) / DP (Drug Product) manufacturing capabilities - Capable of small-scale manufacturing for clinical trials and large-scale manufacturing for commercial production (50L to 2,000L) - Ability to perform aseptic filling and finishing (vials [liquid and lyophilized], pre-filled syringes [PFS], cartridges) *For more details, please download the PDF (English version) or feel free to contact us.*
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Applications/Examples of results
【Usage】 ■ Supports batch sizes from 1,000 to 100,000 vials ■ Robust quality control system ■ Operations compliant with PIC/S GMP, adhering to international regulations ■ Integration of LIMS (Laboratory Information Management System) and QMS (Quality Management System) to enhance efficiency in quality control and assurance ■ Fast and cost-effective solutions *For more details, please download the PDF (English version) or feel free to contact us.
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Company information
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.