Amaran Biotechnology Inc.
Description
Amaran Biotechnology, Inc. is a contract development and manufacturing organisation (CDMO) established in 2010, dedicated to providing high-quality solutions in drug process development, analytical services, and cGMP manufacturing of high-value biopharmaceuticals.
Located in the Hsinchu Biomedical Science Park, Zhubei City, Taiwan, Amaran Biotech operates a state-of-the-art facility designed and constructed between 2013 and 2015, which received PIC/S GMP certification from the Taiwan Food and Drug Administration (TFDA) in June 2017. Under the leadership of Chairperson and General Manager Dr. Tessie M. Che, the company strives to set the gold standard in Taiwan for manufacturing safe and high-quality pharmaceuticals that comply with global regulatory requirements.
Key Products and Services:
Adjuvants: Development and production of adjuvants to enhance vaccine efficacy.
Drug Substance Manufacturing: Process development and cGMP-compliant manufacturing of drug substances.
Drug Product Manufacturing: Utilisation of advanced technologies, including Taiwan's first robotic aseptic-filling system, to ensure precision and sterility in drug product manufacturing.
Stability Study & Analytical Science Services: Comprehensive analytical and stability testing services to ensure product quality and compliance.
Sourcing & Consultation Services: Expert guidance on sourcing materials and navigating regulatory landscapes.
With a commitment to excellence and continuous investment in cutting-edge technologies, Amaran Biotech positions itself as a trusted partner for clients worldwide, offering end-to-end solutions from clinical development to commercial manufacturing.