Thousand Oaks Biologics Achieves EU QP Declaration at Shanghai ADC Facility

Thousand Oaks Biologics, a leader in biopharmaceutical manufacturing, has marked a significant achievement in its operations. The company’s Shanghai facility dedicated to antibody-drug conjugates (ADC) has successfully received an EU Qualified Person (QP) Declaration following a thorough audit. This accomplishment is a testament to the site’s adherence to the high standards set forth by European Union Good Manufacturing Practices (GMP).

Audit Overview

The crucial audit took place over five days in July 2025, led by a seasoned EU QP. During this extensive evaluation, the auditors examined various aspects of the facility, including the quality management systems, production capabilities, equipment, and control processes related to materials.

According to the report, the inspection team was particularly impressed with the state-of-the-art facilities at Thousand Oaks and the rigorous quality management systems that are in place. Key focus areas for the audit included sterility assurance, data integrity within computerized systems, and materials management practices. They also reviewed critical manufacturing processes such as upstream drug substance production, downstream processing, conjugation, and aseptic fill-finish of the ADCs.

Implications of EU QP Declaration

By achieving the EU QP Declaration, Thousand Oaks Biologics has not only confirmed the quality capabilities of its Shanghai facility but has also solidified its position in the international pharmaceutical market. This certification is expected to fast-track the entry of domestic innovators in the ADC sector into global supply chains, demonstrating the vast potential of Chinese Contract Development and Manufacturing Organizations (CDMOs).

Since the establishment of the EU QP system in 1975, companies worldwide have recognized it as a benchmark for pharmaceutical quality assurance. The legal responsibilities assigned to QPs during batch release are clearly defined, ensuring that products meet stringent safety, efficacy, and quality criteria before they reach patients.

Future Directions

This milestone is just the beginning for Thousand Oaks Biologics, as it plans to leverage this certification to enhance its ADC technology platforms. The company aims to improve conjugate screening, process development, and purification processes while also expanding its capabilities in GMP-compliant manufacturing for clinical and commercial drug products.

Moreover, Thousand Oaks is committed to optimizing processes, managing changes, and conducting product comparability studies, which will expedite its global business development efforts. The company is focused on providing integrated, high-quality services from early-stage research and development through to commercial manufacturing.

Thousand Oaks Biologics is dedicated to supporting the development and delivery of innovative therapeutic solutions to meet the needs of patients worldwide. With this new QP Declaration in hand, the company is well-positioned to enhance its operational capabilities and continue to excel in the biopharmaceutical industry, contributing to advancements in patient care and treatment outcomes.

Through its ongoing commitment to quality and innovation, Thousand Oaks Biologics is set to play a pivotal role in the evolution of the ADC landscape on a global scale.