13 July 2022 | News
The world's first gloveless, automated robotics arm aseptic filling system helps the pharma sector to establish an aseptic production and filling line
Photo Credit: PRNewswire
Amaran Biotechnology Inc., a subsidiary of Taiwan's OBI Pharma Inc., has completed the construction of its fully-automated aseptic filling line and facilities, a first in Taiwan.
The new offering reinforces Amaran Biotech's recognition as a leading CDMO 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 Original Equipment Manufacturer (OEM) of active pharmaceutical ingredients (APIs) of OBI Pharma's active immune-oncologic therapeutic products. The project is now entering the final process validation phase of the medium fill procedures.
Amaran Biotech's Quality Management Vice President Jamie Hung says, "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. Using single-use consumables technology, the system not only improves the efficiency of pharmaceutical products but also prevents the risks associated with cleaning validation and cross-contamination issues with conventional DP filling lines." The was completed in two years.
The system can fill vials, pre-filled syringes and cartridge formats ranging from 0.1 to 50mL with a filling precision of 99.99%, suitable for filling of high-value liquid-type biopharmaceuticals. The system can be integrated with the lyophilization process in the future to provide customers with more CDMO service options.