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Purifying natural products is a highly specialized process that demands precision, scientific rigor, and strict quality control. Each stage must be justified not only for technical efficiency but also for regulatory compliance, risk mitigation, reproducibility, and cost-effectiveness. From active pharmaceutical ingredients (APIs) to high-value bioactives, every process step must align with Good Manufacturing Practice (cGMP) standards while maintaining scalability and production efficiency.  Below are Critical Steps in Natural Product Purification,  1. Raw Material Sourcing & Pre-treatment: Carefully selecting a stable, well-characterized source (plant, microorganism, marine organism, etc.) — and confirming species, origin, harvest time, and quality — ensures process stability. Pre-treatment […]

The highly anticipated annual biotechnology event — BIO Asia–Taiwan 2025 Exhibition— will be held from July 24 to 27 at the Taipei Nangang Exhibition Center. Amaran Biotech is proud to debut its new brand identity and vision, showcasing major advancements in aseptic filling line, adjuvant technologies, and global partnerships. Visit us at Booth M726, located in the CDMO zone — we warmly welcome industry partners for dialogue and collaboration. As a one-stop Contract Development and Manufacturing Organization (CDMO), Amaran Biotech provides integrated solutions encompassing vaccine adjuvant AB-801 (QS-21), drug substance manufacturing, and aseptic filling of drug products. With the implementation of a […]

A High-Efficiency Alternative to GC-MS for Commercial-Scale Product Testing GC-MS is commonly used in early-stage development of pharmaceuticals and biotech products due to its high sensitivity and selectivity, particularly for limited, complex samples requiring structural identification. However, as the product moves into commercial-scale production, the high cost and operational complexity of GC-MS become burdensome for routine quality control. Amaran Biotech successfully assisted clients in converting their GC-MS method for residual solvent analysis to a more efficient and stable GC-FID method. Three Key Advantages of GC-FID Implementation:🔹 Enhanced Efficiency: Ideal for situations requiring a large number of repeated analyses, routine quality […]

To help the pharmaceutical industry meet upcoming regulatory requirements, we have successfully completed tooling for pre-filled syringes and are advancing to the next phase of testing preparation and service deployment. With USP <382> set to be implemented in December 1 2025, regulating the functional suitability of elastomeric components (such as plungers) in parenteral packaging and delivery systems. Testing services will be available shortly to support your compliance and quality assurance needs.

In 2025, Amaran Biotech has advanced its digital transformation, aligning with its vision of an AI-driven factory while adhering to GxP compliance standards. By implementing advanced technologies, including Asana, an electronic work /project collaboration system, electronic Quality Management Systems (eQMS), and Computerized Maintenance Management Systems (CMMS), Amaran has significantly enhanced operational efficiency and compliance.

Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), was honored with the "Best CDMO in Automated Aseptic Filling" award at the Taiwan Biopharma Excellence Awards 2025, held yesterday (March 26) at the Hilton Taipei Sinban. Organized by the renowned international consulting firm IMAPAC, the award recognizes Amaran Biotech’s outstanding contribution to advancing automated aseptic filling solutions in the biopharmaceutical sector.

Water for Injection (WFI) is a high-purity water essential to the pharmaceutical, biotech manufacturing, and related industries. Unlike regular purified water, WFI must meet the strictest pharmacopeial standards, such as those set by the United States Pharmacopeia (USP). As a fundamental carrier that may be directly injected into the human body, WFI requires significantly higher purity than industrial or potable water.