HSINCHU, July 13, 2022 /PRNewswire/ — Amaran Biotechnology Inc., a subsidiary of Taiwan’s OBI Pharma Inc., today announced that the construction of its fully-automated aseptic filling line and facilities, a first in Taiwan, has been completed. The new facility minimizes 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. The new offering reinforces Amaran Biotech’s recognition as a leading CDMO (contract development & manufacturing organization) 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’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. We are thrilled that Amaran Biotech is the first company in Taiwan to successfully introduce the system. 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 U.S. FDA, EU’s EMA, ICH, PIC/S and ISPE. The aseptic production line was completed in two years.
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 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.
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). Another anticipated product of Amaran Biotech is the vaccine adjuvant AB-801 (QS-21), produced with a sophisticated technological process from the soap bark tree (Quillaja Saponaria) from Chile, Bolivia, and Peru. The vaccine adjuvant forms the basis of a new strategic partnership with Croda, a British company listed on the London Stock Exchange, to develop applications for the global vaccine market. The compound will also serve as an adjuvant for the new COVID-19 vaccine BCVax developed by Taiwan’s OBI Pharma Inc. Such saponin based adjuvants are currently used in various types of vaccines, such as the Shingrix® Herpes Zoster vaccine by GSK and the Novavax COVID-19 vaccine.
Attachment. Formats of Amaran Biotech’s Fully-automated Aseptic Filling Line:
|
Filling types |
Capacity |
|
Vials |
2R-30R |
|
Pre-filled Syringe |
1-3 ml |
|
Cartridge |
1-1.5 ml |
About Amaran Biotechnology
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. http://www.amaran.com.tw/
SOURCE Amaran Biotechnology, Inc.
