Amaran Biotechnology, a pharmaceutical CDMO and subsidiary of Taiwan's OBI Pharma, has announced that the construction of its fully-automated aseptic filling line and facilities, a first in Taiwan, has been completed.
The new facility minimises the risks of human factors affecting the quality of the pharmaceutical products, and substantially enhances their safety. The project is now entering the final process validation phase of the medium fill procedures.
Amaran chose Vanrx's SA25 workcell for this project, a company based in Canada, and the aseptic production line was completed in two years.
Single-use consumables technology not only improves the efficiency of production, but also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines
Amaran Biotech’s Quality Management Vice President Jamie Hung said: “Vanrx SA25, the soon-to-be commissioned fully-automated aseptic filling equipment, originates from Canada and is the first gloveless, automated robotics arm aseptic filling system in the world."
"We are thrilled that Amaran Biotech is the first company in Taiwan to successfully introduce the system," Hung added. "Using single-use consumables technology, the system not only improves the efficiency of pharmaceutical production, but also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines.”
In preparation for the system introduction, the facilities of Amaran Biotech were planned and designed according to the international regulatory guidelines including the US FDA, EU’s EMA, ICH, PIC/S and ISPE.
The new capabilities
Amaran Biotech’s fully-automated aseptic filling line integrates a gloveless isolation system and robotic arms to perform loading/unloading, filling, capping, sealing and inert gas replacement operations with advanced automation. Personnel intervention is not needed during the process to complete the operations.
The system can fill vials, pre-filled syringes and cartridge formats ranging from 0.1 to 50 mL with a filling precision of 99.99%, suitable for filling high-value liquid-type biopharmaceuticals. The system can be integrated with the lyophilisation process in the future to provide customers with more CDMO service options.
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The new offering reinforces Amaran Biotech’s recognition as a leading CDMO (contract development & manufacturing organisation) with many years of extensive experience in the development of manufacturing processes of high-value biopharmaceuticals, analysis services, and premium solutions for cGMP production. It also strengthens its position as the OEM of active pharmaceutical ingredients (APIs) of OBI Pharma’s active immune-oncologic therapeutic products.
Amaran Biotech will join the 2022 Bio Asia-Taiwan at the end of July, where the new system will be the main pillar in the company presentation. The company will also exhibit in the newly established CDMO hall (Booth#R320).