Amaran Biotechnology Inc. is a contract development & manufacturing company specializing in drug process development, analytical services and cGMP manufacturing of high-value biopharmaceuticals. Amaran Biotech’s state-of-the-art manufacturing facility is located in the Hsinchu Biomedical Science Park and has been granted the PIC/S GMP certification from the TFDA since 2017. The company has also 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. through stock-for-stock exchange and officially became a subsidiary of OBI Pharma Inc. Dr. Tessie Che, Chairperson and General Manager of Amaran Biotech, has decades of experience in the global pharmaceutical and biotechnology industry. 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.
Amaran’s product and services:
- AB-801 Adjuvant: High quality GMP grade saponin vaccine adjuvant (QS-21)
- Drug Substance Manufacturing
- Carbohydrate synthesis, protein glycosylation under lower oxygen level
- Ozonolysis at low-temperature
- Protein and natural product purification
- Bioconjugation
- Drug Product Manufacturing
- All-in-one robotic isolator for aseptic fill finish
- Low filling process loss
- Gloveless, no human intervention
- Suitable for vaccine and early phases of clinical IMP production
- Ideal for precision medicine and new generation therapeutics
- Stability Study & Analytical Services
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- 4 storage conditions for stability samples
- Material and product testing/release
- Analytical method development/validation
- Microbial testing service
- Antibody potency assay
- Contral lab management
Website: http://www.amaran.com.tw/