For pharmaceutical companies, biotech ventures, and generic drug companies! Consistent DS/DP manufacturing within the same facility.
We would like to introduce the contract development and manufacturing services for ADCs (Antibody-Drug Conjugates) provided by Mycenax Biotech Inc. Mycenax's main capabilities include end-to-end biopharmaceutical development and manufacturing, contract development and manufacturing services for monoclonal antibodies (mAbs), dual/multiple specificity antibodies, ADCs, and flexible DS (drug substance) / DP (drug product) manufacturing capabilities. Additionally, we are capable of aseptic filling finishes (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 monoclonal antibodies (mAb), bispecific/multispecific antibodies, and antibody-drug conjugates (ADC) - Flexible manufacturing capabilities for Drug Substance (DS) and Drug Product (DP) - Capable of small-scale manufacturing for clinical trials and large-scale manufacturing for commercial production (50L to 2,000L) - Capable of 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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【Usage】 ■ Supports batch sizes from 1,000 to 100,000 vials ■ Robust quality control system ■ Operations compliant with PIC/S GMP and in accordance with 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.
