Basic Information
- Company Name：Mycenax Biotech Inc. (MBI)
永昕生物医薬股份有限公司 - Year of The Establishment：September 2001
- Name of Representative：Pei-Jiun Chen, Ph.D.
- Number of Employees：~200
- Location of Headquarters：4F, No. 50-7, Keyan Road, Jhunan, Miaoli 35053, Taiwan
苗栗県竹南鎮科研路50-7号4階（台湾） - URL：http://www.mycenax.com.tw/en
- Contact Information：
Exclusive Agent in Japan：LibraMedicina, Inc.
Address：Nihonbashi Life Science Bldg 2, Room 704
3-11-5, Nihonbashi-honcho, Chuo-ku, Tokyo 103-0023 JAPAN
TEL：03-6712-7668
E-Mail：biz@lmed.co.jp
URL：https://www.lmed.co.jp/
Questions for the article
1.What are the advantages of your company and/or your services?
Pei-Jiun Chen, Ph.D., the president of Mycenax
Mycenax Biotech Inc. creates comprehensive, better and faster approaches to accelerate the delivery of biopharmaceutical solutions globally. Our advantages include:
- Fully integrated development and manufacturing services for biotechnology companies worldwide.
- Efficient and cost-effective solutions with international standard to meet PMDA/EMA/FDA requirements.
- Adaptability and scalability based on unique needs.
- Collaborative approach to development and commercialization timeline.
2.How competitive you are in the market?
Mycenax is the first company in Taiwan who developed biological drug product from research to the market. We provide end-to-end solution from DNA to GMP and our GMP facility is PIC/S certificated, US DMF registered, and Japan AFM certificated. We offer one-stop-shop biological services, bespoke to individual customer requirements, stretching from R&D to commercialization.
With our strong research base and regulatory support, we have established a full panel of analytical methods, including cell-based bioassay and special binding assay and supported partners to complete more than 26 IND/CTA filings.
Our solid development experience, unique platforms and flexibility enable Mycenax to bring our partners reliable, cost-competitive and real-time biological solutions.
3.What are problems of clients you will resolve in Japan?
The facility of Mycenax’s GMP factory and the first 2000L bioreactor in Asia.
Mycenax offers industry’s most comprehensive R&D and commercial solution continuum. We have wide range of development capacities including cell line development, upstream/downstream/formulation process development, process/ product characterization and analytical services. We also provide GMP manufacturing services for drug substance and drug product.
Mycenax has entered the Japanese market since 2012 in cooperation with its exclusive agency in Japan, LibraMedicina (https://www.lmed.co.jp/) and provided services for more than 10 companies ranging from small-startups to large pharmaceutical companies. We have help customers solving productivity and product stability issues of novel drug projects and collaborate on several biosimilar projects from scratch to clinical production.
Mycenax takes pride in fully integrated service, development and manufacturing excellence, and collaborative approach to partner’s timeline and we can assist Japanese customers to solve the problems in different phases of their projects.
4.What are the short, middle, and long-term objectives of your company?
Mycenax is PIC/S certificated and providing CDMO services complying with ICH guideline. In the short-term, we focus on satisfying our partners, especially in the Asia region including Japan. Our mid-term goal is to expand our capacity and offer our services to global companies and grow with our partners. In the long run, we expect to be the best partner of global biological drug development companies to contribute to biopharmaceutical society and then benefit all human being.
5.Other messages for Japanese clients
Being in the biopharmaceutical industry for almost two decades, we fully understand the difficulties and problems a biological company will face when developing either a novel or biosimilar project/product. Time and cost are the key factors to win biological games. With our expertise, successful experience in biological developments and flexibility, Mycenax will be your reliable partner to deliver you the products better and sooner beyond your expectation.
永昕生物医薬股份有限公司
