リブラメディシーナ List of Products and Services

We would like to introduce the comprehensive microbiological testing, contract research and development, and cosmetic development services provided by Maple Bio Laboratories, Inc. The ability to manufacture cosmetics that ensure stability without the use of preservatives is a unique strength of the company, which specializes in microbial control. This can greatly contribute to the launch and differentiation of natural-oriented brands. Furthermore, the company boasts a flexible and reliable microbiological testing system that can respond on-site to factories and kitchens, as well as the capability to conduct virus testing for influenza, COVID-19, and other viruses. 【Features】 ■ Capable of conducting virus inactivation tests for multiple viruses, including influenza and human coronaviruses ■ Ability to manufacture stable cosmetics without the use of preservatives through microbial control technology ■ Supports both OEM and ODM, providing seamless assistance from formulation design to product commercialization ■ Has unique achievements under the "LeChene" brand *For more details, please download the PDF or feel free to contact us.

• Other Testing Contract

Our company provides comprehensive support for regulatory strategies, including IND applications for pharmaceuticals, CTD/CMC dossier preparation, gap analysis, and bridge study evaluations. We can also assist with the design of First-in-Human (FIH) trials, initial dosing, and PK/PD modeling. Our ability to support everything from Pre-IND strategy design to CMC documentation and compliance with Taiwanese regulations at a lower cost than global CROs is highly attractive for companies aiming for global expansion on a limited budget. 【Features】 ■ One-stop system capable of consistent support from IND applications to CMC dossier preparation ■ Expertise in local regulations, particularly focused on Taiwan ■ High level of specialization in initial dosing and PK/PD modeling ■ Significantly better cost efficiency compared to global CROs ■ Early strategy design at the Pre-IND stage enables shortening of development timelines *For more details, please download the PDF (English version) or feel free to contact us.

• Other Testing Contract

"ADC analysis and bioanalysis" is a service that allows for the simultaneous analysis of low molecular weight compounds as well as high molecules such as proteins and antibodies. This service is particularly useful for startup companies and pharmaceutical companies developing biopharmaceuticals (including ADCs), where there is a need to establish new analytical techniques alongside product development. Mithra has extensive experience and solid technical capabilities in the field of bioanalysis, and we welcome inquiries even at the idea stage or early development phase. Please feel free to contact us. [Features] ■ Accumulated technology for integrated development of low molecular and biopharmaceuticals over many years ■ Particularly rich insights in ADC analysis are highly valued by ADC development companies in Taiwan and abroad *For more details, please download the PDF or feel free to contact us.

• Other analysis and evaluation services

Our company conducts BE and PK tests overseas as part of our support for the research and development of generic pharmaceuticals. Under a quality management system based on PMDA guidelines, we provide services that meet the needs of Japanese pharmaceutical companies. The ability to conduct pilot BE/PK tests overseas in a short timeframe and at low cost is a significant advantage, especially for Japanese generic pharmaceutical companies. 【Features】 ■ Responding to the trend of acceptance of overseas test data by PMDA - Appropriate test design is possible based on advanced PMDA materials/policies. ■ Early test response at pilot scale: Flexible testing even in the initial development stage. ■ Competitive pricing compared to Japanese CROs. ■ High-quality data and quick turnaround. - Accelerates decision-making for the next steps without slowing down development speed. ■ Extensive track record of support for Japanese companies: Detailed responses tailored to needs. *For more details, please download the PDF (English version) or feel free to contact us.

• Other contract services

We provide bioanalysis and method development services from Mithra Corporation (based in Taiwan). Our strong positioning as a top-level bioanalytical lab in Taiwan allows us to accurately meet the high-quality analytical needs that are lacking domestically. Additionally, we have a referral system established by former PPC personnel, which provides a significant advantage in building trust with Japanese companies. 【Features】 ■ A bioanalytical lab boasting top-tier capabilities in Taiwan, capable of meeting global standards. ■ A strong alternative to the few bioanalysis labs available in Japan. ■ Comprehensive support from method development to PK/PD analysis. ■ Japanese language support provided by former PPC BD personnel, ensuring smooth communication with clients. ■ A well-established collaboration and referral system, enabling rapid service deployment in the Japanese market. *For more details, please download the PDF (English version) or feel free to contact us.

• Other bio-related products and services

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.

• Contract manufacturing

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.

• Contract manufacturing

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 is operated in compliance with PIC/S GMP and adheres to 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" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

Our company is the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for biopharmaceuticals from Mycenax Biotech Inc. We offer contract development and manufacturing services that cater to a wide range of modalities, including monoclonal antibodies (mAb), multi-specific antibodies, antibody-drug conjugates (ADC), enzyme preparations, recombinant proteins, cell therapy products, and plasmid DNA. We conduct strict manufacturing management based on PIC/S GMP, and with an integrated system environment of LIMS/QMS, we ensure quality assurance throughout the entire product lifecycle. 【Features】 ■ A highly reliable manufacturing system that meets regulatory requirements ■ Support for minimizing manufacturing risks and rapid development through a consistent manufacturing system for active ingredients and formulations ■ Flexible process adaptation in dedicated manufacturing facilities that accommodate multiple cell lines ＼ For more details, please check "Download Catalog" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

Our company is the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for biopharmaceuticals from Mycenax Biotech Inc. We offer contract development and manufacturing services that accommodate a wide range of modalities, including monoclonal antibodies (mAb), multi-specific antibodies, antibody-drug conjugates (ADC), enzyme preparations, recombinant proteins, cell therapy products, and plasmid DNA. We conduct strict manufacturing management based on PIC/S GMP, enabling quality assurance throughout the entire product lifecycle in an integrated system environment with LIMS/QMS. 【Features】 ■ A highly reliable manufacturing system that meets regulatory requirements ■ Support for minimizing manufacturing risks and rapid development through a consistent manufacturing system for active pharmaceutical ingredients and formulations ■ Flexible process adaptation in dedicated manufacturing facilities that accommodate multiple cell lines ＼ For more details, please check "Download Catalog" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

Our company is the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for Mycenax Biotech Inc.'s biopharmaceuticals. Mycenax is capable of contract development and manufacturing for a variety of biopharmaceuticals, including antibody drugs. The target formulations include monoclonal antibodies, multi-specific antibodies, ADCs, enzymes, recombinant proteins, cell therapy products, and plasmid DNA. High-quality and efficient manufacturing is possible at our PIC/S GMP-compliant facility that adheres to international standards. With the implementation of a Quality Management System (QMS) and LIMS, we are fully prepared for audits. 【Features】 ■ Compliance with international regulations and proven track record with regulatory inspections ■ Smooth project progress with one-stop manufacturing for DS/DP ■ Equipped with dedicated facilities to support the production of diverse cell lines and high-potency formulations ＼ For more details, please check "Download Catalog" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

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 are conducted in compliance with PIC/S GMP and adhere to 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" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

Our company is the exclusive agent in Japan providing contract manufacturing and GMP contract manufacturing (CRO/CMO) services for Mycenax Biotech Inc.'s biopharmaceuticals. Mycenax is capable of contract development and manufacturing for a variety of biopharmaceuticals, including antibody drugs. The target formulations include monoclonal antibodies, multi-specific antibodies, ADCs, enzymes, recombinant proteins, cell therapy products, and plasmid DNA. High-quality and efficient manufacturing is possible at facilities compliant with international standards and PIC/S GMP. With the implementation of a Quality Management System (QMS) and LIMS, we are fully prepared for audits. 【Features】 ■ Compliance with international regulations and proven track record with regulatory inspections ■ Smooth project progress with one-stop manufacturing for DS/DP ■ Equipped with dedicated facilities to support the production of diverse cell lines and highly active formulations ＼ For more details, please check "Download Catalog" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

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 are aligned with 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" ／

• Research Antibodies
• Other research reagents
• Other contract manufacturing

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 manufacturing
• Other Contract Life Science Specialization
• Various recombination contracts

One of our founders has built good relationships with Taiwanese bioindustry companies and public research institutions for about 50 years. Additionally, we gather licensing information through our network of affiliated companies in Taiwan, South Korea, Europe, and the United States.

• others

We provide bioanalytical testing services for biopharmaceuticals and small molecules, capable of meeting needs at various stages of development. We specialize in pharmacokinetic analysis of biopharmaceuticals and possess advanced techniques, such as simultaneous analysis of the pharmacokinetics of the antibody portion and the payload portion. Our company offers a comprehensive CRO service, including the planning of biological tests in accordance with ICH Q6B, supporting drug development broadly from exploratory research to application, manufacturing, and clinical trials. For more details, please contact us or download our catalog.

• Other contract services

Our company has sufficient experience and capabilities, and we have entered into business contracts with two reliable CROs to support your clinical trials. 1. Company A (Trials in North America, Europe, and South Korea) With four locations in the United States, four in the EU and Switzerland, and one in South Korea, we provide global trial services and have received positive feedback from many Japanese pharmaceutical companies for being accurate, high-quality, fast, and cost-effective. In global trials, we have experience with 1,000 protocols across approximately 30 countries. 2. Company B (Trials in Taiwan and China) Based in Taiwan, we have been conducting clinical trials for over 30 years since 1988, covering both low-molecular and high-molecular drugs. Clinical trials in Taiwan can be conducted at significantly lower costs compared to those in Japan and Europe, offering the following advantages: - By conducting trials as part of studies in Japan and Europe, case acquisition becomes easier, and the trials can be expedited. - Results from trials conducted at four designated hospitals in Taiwan can be used to apply for approvals from the Chinese government. - Due to long-standing relationships with East Asian and Southeast Asian countries, entering the functional food market in these regions becomes easier.

• others

In "Contract Research Organization (CRO) for Strain Improvement and Fermentation Process Development," partner companies have accumulated extensive experience and achievements in the improvement of production strains for useful substances and recombinant technology, providing research and development services that meet the diverse needs of a wide range of clients. We possess a library of 20,000 strains that produce useful substances. We offer comprehensive and high-quality services regarding strain improvement, in vivo changes, fermentation process development, and the provision of microbial NP libraries. 【Features】 ○ Improvement of metabolite yields ○ Suppression of by-product production ○ Enhancement of fermentation processes ○ Provision of microbial libraries ○ Extensive experience with a wide range of strains For more details, please contact us or download the catalog.

• Other contract services

We provide customized services for the production of metabolites by microorganisms. We offer options for optimizing production and purification processes, as well as improving cost-effectiveness. Additionally, we can accommodate everything from small-scale culture trials to commercial-scale GMP production. *For more details, please download our catalog or feel free to contact us.*

• others

Regarding active pharmaceutical ingredient manufacturing, we support outsourcing at various stages of new drug development and generic pharmaceuticals, from establishing synthetic methods to small-scale trial production for clinical testing (from grams to kilograms), GMP production, and commercial production. We are also capable of GMP production and regulatory registration for highly contained substances such as anticancer drugs, steroids, and highly pharmacologically active materials. In formulation manufacturing, we mediate contract services for formulation development, manufacturing method formulation research, setting quality standards, developing testing methods, and CMC-related tasks. The CDMO we represent complies with GMP regulations in various countries as well as ICH and PIC/S guidelines. Even at the development stage, we conduct process improvements and data management aimed at market launch, supporting smooth regulatory submissions.

• others

In "Synthetic Pharmaceutical Development and IND Package," we will appropriately propose services that meet the client's needs from the early research stage to IND. The main contents include synthetic pharmaceutical CMO/cGMP, label body API synthesis, and IND package (including the preparation of application documents), among others. Services related to ADME, safety, and IND packages are not limited to synthetic pharmaceuticals and can also be provided for biopharmaceuticals. [Main Service Contents] - Compound synthesis - Small-scale synthesis - Process development and industrialization - Radioactive compounds, etc. For more details, please contact us or download the catalog.

• Contract manufacturing
• Other contract services

In the "GLP Safety Testing," we conduct tests tailored to your needs, including toxicity tests, repeated dose tests, safety pharmacology tests, developmental and reproductive toxicity, and biocompatibility tests. All tests conducted are audited by an independent Quality Assurance Unit (QAU) and compiled in compliance with GLP. 【Features】 ○ Supported by a group of toxicity and pathology researchers and experts in laboratory animals ○ All tests conducted are audited by the Quality Assurance Unit ○ Designed to meet the regulatory requirements of various different countries where products are marketed ○ Providing GLP services by experts in accordance with the corresponding guidelines For more details, please contact us or download the catalog.

• Other contract services

In "Pharmacokinetics and Clinical Pharmacology," we provide contract services regardless of the size of the molecules, including biopharmaceuticals and chemically synthesized products. We comprehensively offer the necessary tests for IND packages, including safety pharmacology, pharmacokinetics and metabolism, in vitro and in vivo metabolism, among others. For this service, we have multiple options, and the experts in drug development at Libra Medicina Co., Ltd. will propose services tailored to your company's needs. 【Services】 [Pharmacokinetic Testing] - Evaluation of bridging studies - Preclinical pharmacokinetic research - Toxicokinetic studies - Clinical pharmacokinetic testing - Bioavailability (BA) and bioequivalence (BE) studies, etc. For more details, please contact us or download the catalog.

• Other contract services

1. GLP bioanalysis services compliant with ICH-Q6B for biological products: recombinant proteins, monoclonal antibodies, antibody-drug conjugates (ADCs), vaccines, peptides, glycoproteins. 2. Pharmacokinetics, DMPK, and bioanalysis services for chemical drugs: We provide biological testing services at all stages of drug development, including preclinical, clinical, and post-marketing, not only for biopharmaceuticals but also for small molecule drugs.

• others

1. Pharmaceutical Development Consulting We provide support services for the design of development plans and the implementation of preclinical and clinical research. 2. Consulting for Medical Device and Medical Equipment Development Our staff is a team of professionals with experience in medical device development (preclinical and clinical trials) and application processes. 3. Functional Food Development Consulting We have extensive experience in the development planning, preclinical evaluation, and clinical trials of various functional foods. 4. Introduction of New Pharmaceutical Seeds and Platform Technologies We have a network not only with overseas pharmaceutical and biotech companies but also with domestic and international ventures and academia.

• others

We are currently offering a summary of the bioanalysis testing services provided by Libra Medicina Co., Ltd.! There are multiple analytical methods available, and the experts in pharmaceutical development at Libra Medicina Co., Ltd. will propose services tailored to your company's needs. 【Examples of Services】 <Bioanalysis Testing Services> 　■ Protein Analysis 　■ Pharmaceutical Analytical Method Services 　■ Clinical Trial Services <Pharmaceutical Development Services> 　■ Drug Safety and Metabolism 　■ Compound Development <Non-Clinical Testing Services> 　■ Mammalian Animal Testing 　■ Genotoxicity, etc. *For more details, please contact us or download the information from the link below.

• Other contract services

We are collecting candidate products without specifying a particular therapeutic area, focusing on novelty and innovation. As of now, our achievements include oncology, cell therapy, gastroenterology, respiratory medicine, dermatology, hematological diseases, radiology, analgesics, ophthalmology, and platform technologies.

• others

・Postbiotics ・Mushroom products ・Microbial producs

• others