Our prolific experience in cell line development of NBEs and Biosimilars as well as the stable and robust BNS host cellTM allows us to generate top performing cell lines with high product quality.
Our proficiency in process development and large scale manufacturing extends from pre-clinical to commercial, and enhances consistent performance from R&D to manufacture.
With our practice in consultation for large scale and commercial process, regulatory support, micro-scale and large-scale equipment and instruments, as well as strong operational skills, we provide a vast array of services and programs.
Bionova Scientific, Inc. was founded by a group of biopharmaceutical specialists and is located in Fremont, CA. This biologics company presents world-class expert services for cell line development including new biological entity (NBEs) and Biosimilars, cell culture process development, as well as scale- up and tech transfer support in generating biologic medical products.
Bionova Scientific, Inc. has been developing stable cell lines for commercial application. The company has built expertise in protein production from mammalian cell culture. This includes expression system optimization, host adaptation, media selection, cell culture process development for scale-up, and assay development for product quality.
DHFR-deficient CHO cell line DUX-B11 is used for cell line development and is qualified for use in commercial applications. The host was adapted in-house to chemically defined animal component free suspension culture.
9 cell lines for monoclonal antibody and glycoprotein drug production have been successfully created using the BNS Cell Line PlatformTM. With the BNS Process PlatformTM, toxicology material was generated from 750 L pilot scale bioreactor and GMP campaign was completed using two 2 kL product bioreactors. This product is currently in phase II of clinical trial studies. Two products are submitted for IND filing. Production quality data package from three products is completed and ready for a partnership.
With the “know-how” expertise on cell line development, process development, commercial manufacturing, facility design including R&D laboratory, Pilot Plant and GMP manufacturing, new technology evaluation and regulatory support, Bionova Scientific, Inc. delivers guaranteed high quality services to clients.
Vision: To become the world’s leading biopharmaceutical CRO and CDO service company through platform technologies and quality services
Mission: To support biopharmaceuticals and to contribute to the health of mankind
Core Value: Together We Grow and Develop
Bionova Scientific, Inc. was founded by a highly dedicated specialist team that strives for excellence in quality with an affordable budget for every project. The company is led by a seasoned management team with more than 50 years of experience in the biopharmaceutical industry.
Bionova Scientific, Inc.
48521 Warm Springs Blvd. Suite 311
Fremont, CA 94539