Company Growth

Excelsior Bio-System Inc. (EBS) is a fully integrated medical device manufacturer with research, development, manufacturing, and production capabilities. Established in October 2004 at the incubation center of the Industrial Technology Research Institute (ITRI), the company specializes in "immunofluorescence assays" as a platform, providing solutions for biological immune system diagnostics and health management. Excelsior Bio-System is committed to advancing the management of symptoms caused by allergic reactions in humans and animals.
Milestones in Development:

2004: Excelsior Bio-System (EBS) was established, with early efforts focused on foundational experiments and process development.
2007: Raised additional capital with Mr. Cheng. The company relocated to an operational center in Taipei (7F, No. 8, Lane 143, Xinming Road, Neihu District), establishing dedicated R&D and testing departments.
2010: Transitioned from a biotech and technical services company to a fully developed manufacturer. Established a GMP-certified facility with nine ISO 14644-1 compliant cleanrooms. Introduced a research laboratory and quality control lab to enhance product innovation and maintain quality standards.

Key Achievements and Certifications:

In 2011, received a manufacturing registration certificate for "in vitro diagnostic reagents for animal use" and ISO 9001:2008 certification for its quality management system.
Achieved ISO 13485 and GMP certification in 2012, marking a significant step in becoming a complete medical device manufacturer.
Obtained CE IVD certification for the European Union in 2013.
Launched innovative products, including the "African Swine Fever Rapid Test Kit" (2018) and the "COVID-19 Antibody Rapid Test Kit" (2020), becoming a pivotal contributor to Taiwan's pandemic response as part of the national prevention team.

Recent Progress and Global Expansion:

2020-2022: Developed and received emergency manufacturing approval for a suite of COVID-19 diagnostic reagents, including professional and at-home antigen rapid test kits and neutralizing antibody ELISA tests.
2023-2024: Actively expanded into international markets, including Canada, the United States, Malaysia, South Korea, Japan, China, and Vietnam.
May 2024: Secured WOAH (World Organisation for Animal Health) certification for the African Swine Fever Rapid Test Kit.

Excelsior Bio-System continues to innovate in immunofluorescence assays, ELISA, and rapid diagnostic testing, upholding stringent quality standards under the latest ISO and GMP certifications to ensure safe and effective in vitro diagnostic solutions.