Join-Bio

Beijing Join-Bio Pharmaceutical Technology Co., Ltd. was established in early February 2018, committed to becoming the most trusted and leading biopharmaceutical CDMO enterprise for customers. Currently, the company has a core technical team with extensive industry experience and familiarity with Chinese and foreign new drug regulations, as well as engineering cell lines with full intellectual property rights. Based on R&D and production bases in both China and the United States, the company provides global innovative drug R&D institutions with one-stop solutions from cell line construction, developability studies, process scale-up optimization, quality research, pilot and commercial production. High-standard production and experimental bases: Join-Bio has built a production facility in the U.S. with a scale of 1000L+2×500L+200L, meeting FDA GMP standards, with thousand-liter production capacity; in Beijing, Join-Bio has built production lines of 2×500L+2×200L scale with supporting PD and R&D experimental facilities, and is constructing a 100,000-liter scale drug substance production line and high-end formulation workshops for various dosage forms such as lyophilized, aqueous injections, and pre-filled syringes, meeting GMP standards of China, the U.S., and the EU. Engineering cell lines with full intellectual property: Possessing CHO cell lines and expression systems with full intellectual property rights, as well as CHO cell culture and purification platform processes capable of meeting pilot and commercial production scales for monoclonal antibody drugs; with capabilities in quality standard development, release testing, and structural characterization for monoclonal antibody drugs. International team and production quality system: The dual facilities in China and the U.S. jointly build a production and quality system that meets international standards, satisfying regulatory requirements for dual filing in China and the U.S. Experienced and superior international team: Join-Bio has a core technical team of nearly 300 people combining Chinese and American expertise, with nearly 100 experts having overseas work backgrounds, and nearly 20% of experts with over 15 years of experience in protein drug R&D and production.