HSINCHU, Sept. 25, 2024 /PRNewswire/ — Amaran Biotech, a leading Taiwanese CDMO (Contract Development & Manufacturing Organization) offering comprehensive pharmaceutical development and manufacturing solutions, will debut at BioJapan 2024 in Yokohama from October 9-11. The company is participating as part of Taiwan’s Biotechnology and Pharmaceutical Industries Promotion Office (BPIPO) delegation. Amaran Biotech will showcase its services at the Taiwan Pavilion (Booth No. B-56), including its vaccine adjuvant AB-801 (QS-21), drug substance manufacturing, drug product manufacturing, and stability study and analytical science services. Visitors are invited to meet with Amaran Biotech’s representatives at the event.
Amaran Biotech owns Taiwan’s first fully automated robotic sterile filling line, equipped with the highly competitive Cytiva SA25 robotic filling system. This system provides high-quality, low-waste filling solutions for clients’ high-value new technologies and drugs. Since its successful introduction in 2022, business inquiries and new clients have significantly increased. Moving forward, Amaran Biotech plans to further develop production lines in response to industry trends and collaborative development progress, including sterile filling for newly designed antibodies and vaccines, gene therapy drugs, new complex drugs, and new formulations, aiming to serve a broader range of clients. In drug substance manufacturing, Amaran Biotech excels in glycoprotein complex bonding, helping clients successfully apply for clinical trials, which have been accepted by the U.S. FDA. Amaran Biotech’s flagship product, the AB-801 (QS-21) adjuvant, is currently being co-developed with a publicly listed UK company for global vaccine development and application. Looking ahead, the company will focus on sustainable and innovative cultivation methods, striving for kilogram-scale production while ensuring the continuous supply of raw materials and protecting natural resources.
Amaran Biotech’s state-of-the-art manufacturing facility is located in the Hsinchu Biomedical Science Park in Taiwan and has been granted the PIC/S GMP certification from the TFDA since 2017. The company has been audited and fully qualified by the regulatory agencies and third-party auditors from USA and EU. In 2020, Amaran Biotech strengthened its collaboration with Taiwan’s OBI Pharma Inc. and became a subsidiary of OBI Pharma Inc. In 2024, Building C received the Green Building Certification from Taiwan’s Ministry of the Interior. Dr. Tessie Che, Chairperson and General Manager of Amaran Biotech, has decades of experience in the global pharmaceutical and biotech industries. During her tenure at Optimer Pharmaceuticals, Inc., she led the CMC team to successfully register and commercialize the antibiotic drug DIFICID® (Fidaxomicin) in the U.S., Canada, and Europe.
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Source : Amaran Biotech Makes Its Debut at BioJapan 2024 in Yokohama
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