Zencore Biologics Co., Ltd., registered in Lin-gang New Area, Shanghai Pilot Free Trade Zone, China, operates as an “independent” Contract Development and Manufacturing Organization (CDMO), i.e., it does not participate in or invest in any business as a Market Authorization Holder of drugs.
Zencore specializes in providing R&D and manufacturing support to biopharmaceutical clients for products in the clinical development or commercial production phase. Leveraging extensive experience and technical expertise, Zencore offers comprehensive biologics CMC (Chemistry, Manufacturing, and Controls) services. These services include developability assessment, stable cell line development, process development, analytical development/transfer/validation, drug substance manufacturing, drug product fill/finish/packaging, lot release testing, stability studies, regulatory submission support, as well as the development and manufacturing of mammalian cell culture media.
With two CDMO facilities totaling 600,000 square feet, Zencore provides pilot scale production with 4×200L and 1×500L single-use bioreactors, as well as state-of-the-art commercial GMP manufacturing services with 3×2,000L single-use and 3×5,000L stainless steel bioreactors in separate production suites. These capabilities are complemented by corresponding purification, formulation, fill and finish lines.
21st century is the era of biotechnology and biopharmaceutical industries. Rapid advancements in life sciences, technologies, and healthcare have brought numerous previously untreatable diseases under control with a significant improvement in patient survival rates and quality of life. These changes have presented many opportunities and challenges for CROs and CDMOs to support the R&D of biopharmaceutical industries. With the aspiration to contribute to a healthier world, Zencore Biologics was established.
A purposeful enterprise requires a group of professionals with ambition, vision, and passion. Zencore is privileged to work with many experienced entrepreneurs, talented scientists, and skilled engineers who share our common aspirations and values.
Since its establishment in 2017, Zencore has continuously innovated in technologies and bioprocesses to improve operational efficiencies. We have been at the forefront of supporting the growth of biopharmaceutical R&D and have earned a good reputation among our global clients.
With a strong belief in "Of the people, by the people, for the people", we will unleash huge potential and creativity. Adhering to our principles of "Pursue the Truth, Commit the Utmost, Strive for Excellence", and alongside our clients, we will create a better and healthier world.
Jianxin Chen ,CEO of Zencore Biologics Co., Ltd.
Zencore boasts a professional management team with extensive experience in drug discovery, development, manufacturing, quality assurance, quality control, analytical science, analytical development, and regulatory affairs both in China and internationally. Members of the leadership team, having returned from positions at multinational companies abroad, have a proven track record of establishing successful biotech ventures in China. They have assembled a skilled mid-level technical team, with each member bringing more than 10 years of average experience in the biopharmaceutical industry, and some have contributed to significant technological advancements in the field. The company now has nearly 700 employees.
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Since its establishment in 2017, Zencore Biologics has become the industry leader in large-scale mammalian cell culture technology. Our team has achieved the record high expression level in the fed-batch culture process for antibody production, which currently stands at 15 g/L.
To date, Zencore Biologics has helped customers complete 30 IND and 3 BLA projects, with more than 200 project experiences overall.
Adhering to our values of pursuing facts, committing to the utmost, and striving for excellence, we aim to deliver the best and cost-effective solutions for our customers.
