SHANGHAI, Oct. 13, 2025 -- Thousand Oaks Biologics' antibody-drug conjugate (ADC) manufacturing site successfully passed an audit conducted by a European Union Qualified Person (QP) and formally received a QP Declaration. This milestone certifies that the company's quality management system and commercial production capability in the field of antibody-drug conjugates (ADCs) comply with EU Good Manufacturing Practice (GMP) standards, positioning Thousand Oaks Biologics Shanghai as one of the few CDMOs in China offering end-to-end international ADC services.
The five-day on-site audit took place in July 2025 and was led by an experienced senior QP. The assessment was conducted in accordance with EudraLex Volume 4 and relevant PIC/S guidelines. The company's quality and production management systems, facilities, equipment, material controls, and packaging and labeling processes were comprehensively evaluated. Key focus areas included sterility assurance, computerized systems and data integrity, and material management. Critical ADC manufacturing steps—such as upstream drug substance production, downstream processing, conjugation, aseptic fill-finish, and quality control testing—were also thoroughly reviewed.
Throughout the audit, the inspection team recognized Thousand Oaks Biologics Shanghai's state-of-the-art facilities, stringent quality management systems, and highly skilled technical team, concluding that the site meets EU GMP requirements.
Since its establishment in 1975, the EU QP system has served as a global benchmark for pharmaceutical quality assurance, with clearly defined legal responsibilities for QPs in batch release. Thousand Oaks Biologics' successful certification not only demonstrates the quality capabilities of Chinese CDMOs but is also expected to help accelerate the entry of domestic ADC innovators into global supply chains.
This achievement further strengthens Thousand Oaks Biologics' competitiveness in the international biopharmaceutical market. The company will use this accomplishment as a foundation to continue enhancing its ADC technology platforms—including conjugate screening, process development, purification, and analytical methods—while expanding GMP-compliant manufacturing capacity for clinical and commercial drug substances and products. In addition, Thousand Oaks Biologics will advance process optimization, change management, and product comparability studies, speeding up its global business development. By delivering integrated, high-quality services from early-stage R&D to commercial manufacturing, the company remains committed to enabling the development and delivery of innovative medicines for patients worldwide.
