Thousand Oaks Biologics Shanghai ADC Site receives EU QP Declaration

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. 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...

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.

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