Innovax works closely with the National Institute of Diagnostics and Vaccine Development in Infectious Diseases (NIDVD) of Xiamen University to build a unique industry-university-research model and establish a nationwide leading technology innovation and transformation system, which is recognized as the leading team in China and the international first-class team in the field of innovation of vaccine core technologies and application transformation.
NIDVD, headquartered in Xiamen University and one of the core institutions for the research and development of diagnostic reagents and innovative vaccines against infectious diseases in China, was jointly established by Xiamen University and Yangshengtang Group in 2005 with the approval of the Ministry of Science and Technology, and passed the expert assessment and acceptance organized by the Ministry of Science and Technology in December 2009 with “Excellent” rating.
Our R&D center, with an area of about 5,000 m2, is equipped with high-quality and high-standard hardware facilities, such as special equipment worth about RMB 120 million, including liquid mass spectrometer, flow cytometer, high-throughput biochemical analyzer, 8-plex bioreactor, APV high-pressure homogenizer, AKTA protein purification system, high performance liquid chromatography. We have also established a highly efficient process development and evaluation technology platform, scientific protein analysis technology platform (including physical chemistry, biochemistry and immunochemical analysis methods), two 100-L laboratory-scale pilot production lines for bacterial fermentation, one 200-L laboratory-scale pilot production line for cellular fermentation, two 100-L laboratory-scale pilot production lines for stock solution preparation and one production line for preparation filling.
Our pilot-scale base includes a Grade-C purification workshop and a Grade-D fermentation workshop, which are used for all process development and research related to our products under development from laboratory scale to pilot scale and from pilot scale to commercial scale. Our pilot-scale base covers a total area of about 600 m2 and is equipped with production-grade and pilot-scale facilities and equipment for the pharmaceutical process in accordance with GMP regulations, including key process equipment such as sterilization cabinets, stainless steel bioreactors, thermostatic shakers, high-pressure homogenizers, pilot-scale protein purification chromatography systems, production-grade protein purification chromatography systems, manual chromatography columns, and tangential flow ultrafiltration systems.
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