Thousand Oaks Biologics Inc.
Nantong, China
Overview
Company details and contact information.
About
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. About Thousand Oaks Biologics Inc. 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. About Thousand Oaks Biologics Inc. Thousand Oaks Biologics Inc. (TOBio) is a premier provider of comprehensive solutions for the large - scale, compliant production of biopharmaceuticals. Its business portfolio encompasses three key segments: the biopharmaceutical CDMO segment, the cell culture medium segment, and the early - stage research service segment. In the biopharmaceutical CDMO realm, TOBio offers end - to - end CMC solutions, guiding candidate molecules through the entire journey from discovery to clinical and commercial production. Currently, the company has established GMP - compliant production bases in Shanghai. These facilities are equipped to offer one - stop R & D and manufacturing services for a diverse range of biopharmaceuticals, including monoclonal antibodies, bispecific antibodies, fusion proteins, and ADCs. TOBio houses JSBio, a leading domestic brand in serum - free cell culture media. JSBiosciences, a key player in this segment, is dedicated to the research, development, production, and marketing of serum - free, personalized, and chemically - defined cell culture media. In addition to product - related services, JSBiosciences also provides clients with comprehensive upstream solutions, such as cell culture process development and scale - up, as well as customized production of medium formulations. With production bases in china and South Korea, JSBiosciences has achieved an annual production capacity in the kiloton range. Its products and technical services find extensive applications in the production of recombinant proteins, antibody - based drugs, human and veterinary vaccines, and cell therapy products. The early - stage research service segment is propelled by Ginspire Biologics, which is based in Shanghai. Ginspire, specialized in early - stage research, offers a suite of services for innovative molecules in various forms. These services include molecular design, evaluation, optimization, and structural and functional characterization. By collaborating with clients to develop unique innovative molecules or licensing out its self - developed molecules as required, Ginspire conducts multi - dimensional assessments and optimizations in terms of structural function, pharmacology, efficacy, and drug - likeness. This approach significantly enhances the success rate of developing complex innovative molecules, facilitating the efficient progression of promising molecules to the next development phase. Thousand Oaks Biologics Inc. (TOBio), a premier Integrated CMC Solution Provider, focuses on comprehensive solutions for large - scale, compliant biopharmaceutical production. Its business covers three main segments: Biopharmaceutical CDMO, Cell Culture Medium, and Early - Stage Research Services. Its products and technical services find extensive applications in the production of recombinant proteins, antibody - based drugs, human and veterinary vaccines, and cell therapy products. In CDMO, TOBio offers end - to - end CMC solutions at its Shanghai and Nantong GMP bases, serving diverse biopharmaceuticals. JSBio, under TOBio, excels in serum - free cell culture media, providing R&D, production, and customized services with kiloton - scale capacity across China and South Korea. Ginspire Biologics drives early - stage research, offering molecular design, evaluation, and optimization to boost complex molecule development success. This dedication across its business segments underscores TOBio’s unwavering commitment to making biologics more accessible and affordable for humanity.
- Website
- https://tobiopharm.com
- Address
- Building A1, Haimen Biotech and Pharmaceutical Park, Nantong Jiangsu 226133, China | Building B1, Haimen Biotech and Pharmaceutical Park, Riverside New District, Nantong Jiangsu 226133, China
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