Thousand Oaks Biologics Achieves Milestone with EU QP Declaration
Thousand Oaks Biologics has successfully received a significant milestone by obtaining the EU Qualified Person (QP) Declaration for its antibody-drug conjugate (ADC) manufacturing site. This accomplishment testifies to the company’s adherence to stringent quality management systems and commercial production capabilities compliant with EU Good Manufacturing Practice (GMP) standards.
Audit Highlights and Compliance
The achievement followed an extensive audit conducted by a qualified European Union representative. During the five-day evaluation, carried out in July 2025, the audit team meticulously assessed the site’s production processes and quality management systems to verify compliance with the EudraLex Volume 4 and related guidelines. The thorough inspection encompassed vital areas such as sterility assurance, data integrity, and material management, while also scrutinizing critical manufacturing processes, including upstream drug substance production and quality control testing.
State-of-the-Art Facilities
The audit team particularly noted the advanced facilities and the rigorous quality management practices implemented at Thousand Oaks Biologics Shanghai. Their positive feedback highlighted the site’s capability to meet the high standards set by EU GMP requirements, thus placing Thousand Oaks Biologics among the few contract development and manufacturing organizations (CDMOs) in China competent to provide comprehensive international ADC services.
Impact on Global Supply Chains
With the establishment of the EU QP system in 1975, it has become a global standard for ensuring pharmaceutical quality assurance. The successful certification of Thousand Oaks Biologics not only showcases the potential of Chinese CDMOs in the field but also facilitates domestic ADC innovators’ access to global markets, thereby enhancing their competitiveness in the international biopharmaceutical landscape. This achievement strengthens Thousand Oaks Biologics' position by serving as a cornerstone for upcoming advancements in their ADC technology platforms.
Future Endeavors and Commitment to Quality
Looking ahead, Thousand Oaks Biologics is poised to leverage its recent EU QP Declaration to amplify its manufacturing capacity for both clinical and commercial drug substances and products. The company plans to enhance its ADC technology platforms through improvements in conjugate screening, purification processes, and analytical methods. They are also committed to advancing process optimization and product comparability studies, further accelerating their global business development initiatives.
By integrating high-quality services from early-stage research and development through to commercial manufacturing, Thousand Oaks Biologics remains dedicated to advancing medical innovation and providing enhanced therapeutic options for patients around the world.
Frequently Asked Questions
What is the significance of the EU QP Declaration?
The EU QP Declaration certifies that the manufacturing site adheres to strict EU GMP standards, ensuring high quality in production and management.
How long was the audit conducted at the manufacturing site?
The audit took place over a five-day period in July 2025, involving thorough evaluations of various processes and systems.
What are ADCs?
ADCs, or antibody-drug conjugates, are targeted cancer therapies that combine an antibody with a cytotoxic drug, designed to improve treatment specificity.
How does this achievement impact Thousand Oaks Biologics?
This certification enhances their competitiveness on a global scale and facilitates the entry of domestic innovators into international supply chains.
What steps will Thousand Oaks Biologics take moving forward?
The company plans to bolster its ADC technology and manufacturing capacity while committing to advancing quality and optimizing processes.
