Intergrated CMC Solution
One-stop CDMO

We will help you achieve success throughout the process from the early stages of drug development to final launch.

As a comprehensive CDMO that integrates process development and contract manufacturing, Thousand Oaks Biopharmaceuticals Co., Ltd. assists its partners to jointly promote preclinical research, preparation of clinical trial products, and the commercial production of biologics. The core ideas held by the company are to assist the R&D of new drugs, to guarantee the product quality, and to promote industry development. Thousand Oaks Biopharmaceuticals Co., Ltd. ensures the medication safety of patients with a high-standard quality system and tries to make them feel at ease. We are willing to grow with customers and meet their outsourcing needs at all stages of drug development and industrialization.



Advantages
Mature quality system
  • the company has established a GMP system in line with the requirements of IND and BLA filing and commercial production in China and the United States.
  • it receives dozens of customer quality audits every year.
  • it has organized multiple simulation of FDA and NMPA inspections.
  • it is one of the few CDMO enterprises in China holding the Drug Production License of the People's Republic of China.
Rich project experience
  • the company originated from JSBiosciences and was trusted by customers in 2011.
  • The company has since passed the on-site verification by the provincial medical products Administration for preparation of clinical trial products.
  • Multiple projects have obtained IND clinical filing approvals both in China and the United States.
  • The company has extensive experience in the development and cGMP-compliant production of allround biologics such as mAb, BsAb, ADC, fusion protein, and vaccines.
Excellent process development competence
  • One-stop process development and production platform.
  • Unique media customization platform.
  • Excellent upstream cell culture technology platform.
  • Efficient downstream purification process platform.
  • Complete preparation development platform.
  • Industrialization platform with a single batch of 2000L cGMP production experience and 500L perfusion process, and multiple regulatory filings at NDA/BLA stage.
  • Perfusion process industrialization platform.
Integrated cost control strategy
  • the company is committed to helping customers achieve optimal costs through the integration strategy of a cell culture media + CDMO + equipment consumables; it is characterized by the process technology that is represented by the tailor-made cell culture media, and continues to help customers solve process problems, increase production, and improve product quality.
  • the modular production process strategy enables the production of multiple products and batches at the same time, with a fair allocation of production capacity.
High quality and flexible service
  • providing a flexible cooperation mode for customers. More than 30% of customers repeatedly entrust Thousand Oaks Biopharmaceuticals Co., Ltd. with CDMO services.
Digital information security
  • the all-digital data platform of production batch record supports information security and traceability and the data security system may provide comprehensive protection for customers' intellectual property rights.
Professional management team
  • Thousand Oaks Biopharmaceuticals Co., Ltd. has a process development and drug production management team with backgrounds of Amgen, Genetech, Pfizer, Merck, and other world-leading pharmaceutical companies to ensure high-performance and efficient management.
Industry layout focus
  • the company does not make its own products and has no conflict of interest with customers.