Amaran Biotechnology Inc., a subsidiary of OBI Pharma specializing in Contract Development and Manufacturing Organization (CDMO) services for next-generation pharmaceuticals, announced today that it has signed a Memorandum of Understanding (MOU) with Nippon Fine Chemical Co., Ltd., and its Taiwan subsidiary, Zillion Fine Chemicals International Co., Ltd. The three parties aim to deepen collaboration in the field of nanoparticle-based drug CDMO manufacturing while expanding their presence in Taiwan, Japan, and international CDMO markets.
Amaran Biotech, through the close collaboration of its IT, Warehouse, and Quality Management (QM) departments, has successfully implemented a Warehouse Management System (WMS) developed by Unitech Electronics. This system enables fully digitized management for the warehouse operation and the DS and DP production lines of Amaran. As the core of manufacturing and supply chain operations, the WMS oversees the entire material management process—from raw materials to finished products—aiming to optimize product and material handling with high efficiency and low cost.
Lipid nanoparticles (LNPs) have revolutionized the delivery of mRNA therapeutics, providing stability, targeted delivery, and protection against degradation. From COVID-19 vaccines to cancer immunotherapies and genome editing, these systems represent a transformative shift in medicine.
QS-21, a saponin-derived adjuvant extracted from the bark of the Quillaja saponaria tree, has emerged as a key player in the field of vaccine development. Recognized for its ability to enhance immune responses, QS-21 is increasingly being explored as a vital component in vaccine formulations aimed at improving immunogenicity and overall effectiveness.
Based on PIC/S Annex 1 “Manufacture of Sterile Medicinal Products”, it is particularly important to ensure the quality and safety of sterile medicinal products throughout their manufacturing process. QC has played an essential role in the control and reduction of contamination by microorganisms, particulates and endotoxins/pyrogens.
Aseptic filling is the final production stage in the pharmaceutical industry and one of the most critical steps. However, the production process for proteins and new therapeutic modalities in aseptic filling faces numerous difficulties and challenges. To further advance the pharmaceutical industry and enhance the understanding of advanced aseptic filling processes among industry professionals and experts, Amaran and Cytiva will co-host the "Advanced Aseptic Processing Technology for Proteins and New Modalities" Workshop, scheduled to be held on Thursday, November 7, 2024, in Zhubei City.