What's Happening?
Thousand Oaks Biologics' antibody-drug conjugate (ADC) manufacturing site in Shanghai has successfully passed an audit conducted by a European Union Qualified Person (QP), receiving a formal QP Declaration. This certification confirms that the company's quality management system and commercial production capabilities comply with EU Good Manufacturing Practice (GMP) standards. The audit, conducted in July 2025, evaluated the company's quality and production management systems, facilities, equipment, material controls, and packaging and labeling processes. Key focus areas included sterility assurance, computerized systems and data integrity, and material management. The inspection team recognized the state-of-the-art facilities and stringent quality management systems, concluding that the site meets EU GMP requirements.
Why It's Important?
The successful certification of Thousand Oaks Biologics' Shanghai site as compliant with EU GMP standards is a significant milestone for the company and the broader Chinese contract development and manufacturing organization (CDMO) industry. This achievement positions Thousand Oaks Biologics as one of the few CDMOs in China offering end-to-end international ADC services, potentially accelerating the entry of domestic ADC innovators into global supply chains. The certification enhances the company's competitiveness in the international biopharmaceutical market, allowing it to expand its ADC technology platforms and GMP-compliant manufacturing capacity. This development is crucial for the global biopharmaceutical industry, as it supports the delivery of innovative medicines worldwide.
What's Next?
Following the EU QP Declaration, Thousand Oaks Biologics plans to continue enhancing its ADC technology platforms, including conjugate screening, process development, purification, and analytical methods. The company aims to expand its GMP-compliant manufacturing capacity for clinical and commercial drug substances and products. Additionally, Thousand Oaks Biologics will advance process optimization, change management, and product comparability studies to speed up its global business development. These efforts are expected to further strengthen the company's position in the international biopharmaceutical market and support the development and delivery of innovative medicines.
Beyond the Headlines
The certification of Thousand Oaks Biologics' Shanghai site highlights the growing capabilities of Chinese CDMOs in meeting international quality standards. This development may encourage other Chinese biopharmaceutical companies to pursue similar certifications, potentially increasing China's presence in the global biopharmaceutical supply chain. The achievement also underscores the importance of stringent quality management systems and skilled technical teams in maintaining compliance with international standards, which is crucial for the successful delivery of innovative medicines.
