Thousand Oaks Biologics Inc. (Hereinafter referred to as TOBio) is a CDMO enterprise integrating cell culture media, biopharmaceutical development and contract manufacturing related business. It providing customers with one-stop-shop service for biologics including druggability assessment, cell line development, process development and optimization, manufacturing services from early stage to commercial, IND filing and NDA filing, etc.
TOBio has extensive experience in development and manufacturing of monoclonal antibody (mAb), bispecific antibody (BsAb), antibody-drug conjugate (ADC), Fc fusion proteins, and other recombinant protein products in the field of therapeutic biological products. It has successfully delivered nearly 100 biologic CMC projects, TOBio is one of the few CDMO which has successfully passed the pre-approval registration of products and GMP compliance on-site inspection. TOBio industry-leading technical experts with many decades of CMC experience is one of the key drivers that enables accelerated project timelines and reduction of the costs for clients.
TOBio has the manufacturing capacity of 200L, 500L and 2,000L of Traditional Fed Batch and Intensified Fed Batch, as well as Concentrated Fed Batch and Perfusion technology in China. The drug product facilities currently capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system configurations that include vials, prefilled syringes. TOBio advanced CDMO platform with a complete quality management system can meet US FDA, EU EMA, China NMPA, and other countries’ regulatory standards.
TOBio has extensive experience in development and manufacturing of monoclonal antibody (mAb), bispecific antibody (BsAb), antibody-drug conjugate (ADC), Fc fusion proteins, and other recombinant protein products in the field of therapeutic biological products. It has successfully delivered nearly 100 biologic CMC projects, TOBio is one of the few CDMO which has successfully passed the pre-approval registration of products and GMP compliance on-site inspection. TOBio industry-leading technical experts with many decades of CMC experience is one of the key drivers that enables accelerated project timelines and reduction of the costs for clients.
TOBio has the manufacturing capacity of 200L, 500L and 2,000L of Traditional Fed Batch and Intensified Fed Batch, as well as Concentrated Fed Batch and Perfusion technology in China. The drug product facilities currently capable of conducting liquid or lyophilized fills at varying clinical and commercial scales and utilizing a variety of container and closure system configurations that include vials, prefilled syringes. TOBio advanced CDMO platform with a complete quality management system can meet US FDA, EU EMA, China NMPA, and other countries’ regulatory standards.
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