Taizhou Zecen Biotech Co.,Ltd.

Zecen Biotech CO., LTD., founded in 2011, is a leading Chinese diagnostics manufacturer specializing in in-vitro diagnostics devices and reagents. Zecen focus on the Chemiluminescent immunoassay (CLIA) field. With all products CE marked, our market presence currently spreads from across China to other countries including India, Switzerland, Russia etc., Zecen is expanding its footprint to become a global brand.

Zecen is the only enterprise with independent intellectual property rights in the entire chemiluminescence industry chain in China, including reagent, instrument, magnetic microbead, and reagent raw material. Our current products include more than 100 assays, from thyroid, inflammation, diabetes, tumer markers, immune disorders, hormones to cardiac markers. Our ever-expanding test menu helps our customers and collaborators keep up with the demands of healthcare sector. Zecen is striving for innovation and perfection to deliver the best products to the customers.

As a manufacturer, Zecen provide the OEM, ODM and other customized service of all products. We have the core R&D centers and innovative ability to lay a solid foundation for developing the broadest range of CLIA analyzers and test menu. High-quality sales and after-sales links provide the more intimate service. The patent and CE certification give us the confident sending all over the world, and more than 50 companys in the requiement of customized and have a long term coorperation with Zecen.

In 2011, Jiangsu Zecen Biotech Co., Ltd. was established;

In 2012, CMP production was created;

In 2013, CIA1200 registration certificate & 23 kinds of reagent registration certificates were obtained;

In 2014, Taizhou Zecen Biotech Co., Ltd.  was established which is a a high-tech enterprise;

In 2015, 75 kinds of reagent registration certificates were obtained and first listed in overseas markets;

In 2016, acquired Weifang Zecen Biotech Co., Ltd. to enrich the product line; CE certificate and ISO13485 certificate were gotten;

In 2017, got the title of "Outstanding Enterprise of China Innovation and Entrepreneurship Competition"; Outstanding Enterprise of "Entrepreneurship Jiangsu" Science and Technology Entrepreneurship Competition;

In 2018, got the title of "Youth Civilization"; Weifang passed quality management certification; "Top ten innovative and entrepreneurial high-level talents";

In 2019, POCLIA was listed; Jiangsu Zecen Biotech Co., Ltd. was awarded the "Gazelle Enterprise" of Jiangsu High-tech Industrial Development Zone; 13 three-category product registration certificates were obtained;

In 2021, won the "Taizhou Patent Inventor Award".

Contract Development/Manufacturing Organization (CDMO)

The first choice in CDMO for IVD materials and expertise

ZECEN is best known for its research and development of unique markers across a wide range of disorders including thyroid, cancer, hormones，infectious diseases, and cardiac.

Our reputation is built on, not only bringing these markers to the market, but also on developing the clinical evidence in routine use over many years. We have partnerships with many of the world’s diagnostic companies to deliver crucial raw materials, product development support and manufacturing on which they depend.

The complete CDMO package

Our competence to supply IVD raw materials and develop novel biomarkers, uniquely positions us in the market as the primary content provider to the diagnostics industry. Zecen offers diagnostic companies a comprehensive range of products and services from “raw material to finished product”.

Critical raw materials manufacturing

We develop and manufacture core materials and antibodies and have the capacity to supply them at scale anywhere in the world. High quality is guaranteed by CE, ISO certifications, a mature quality system, and the application of the same materials across multiple technologies.

Customization and co-development

We develop core materials ourselves and have the expertise to customize solutions to the technology needs of our customers. Our experts are ready to help and work together with CDMOs to develop the markers of tomorrow, customized to their platform. We have a proven track record of developing assays and providing a level of regulatory consultation that ensures marketability.

Auditing

Our global footprint allows us to meet both the internal quality standards of our partners and the requirements of national or regional regulatory bodies with regard to manufacturing and product quality standards.

Continuous development

On our own and in partnership with global researchers, we continue to develop new markers which will add value to the clinical management of patients. Access to these new markers helps our partners refresh and expand their product portfolios more ly and efficiently. We develop long term partnerships based on the shared desire to meet the world’s ever-changing clinical needs.

Branches

Beijing/Jiangyin city： R&D

Taizhou city：POCT、CLIA
Weifang city: Biochemical