#China #Shanghai #ADC Manufacturing #Thousand Oaks Biologics #EU QP Declaration

Thousand Oaks Biologics Achieves Esteemed EU QP Declaration

Thousand Oaks Biologics has made significant strides in the biopharmaceutical landscape with its recent achievement of an EU Qualified Person (QP) Declaration at its Shanghai facility. This accomplishment was solidified after an extensive audit performed by an experienced QP from the European Union.

Overview of the Audit

The audit, which took place over five days in July 2025, was comprehensive in nature. It followed stringent guidelines set forth in EudraLex Volume 4 and aligned with the relevant standards of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The inspection's focal points included the evaluation of the company's robust quality management system and the efficiency of its commercial production capabilities concerning antibody-drug conjugates (ADCs).

Key areas that received thorough examination included:

• - Sterility Assurance: Ensuring that the manufacturing processes minimize contaminants that can affect product safety and efficacy.
• - Computerized Systems and Data Integrity: Critical in maintaining accurate records and compliant operational standards.
• - Material Management: Overseeing the shipment, storage, and utilization of materials to comply with good manufacturing practices.

Additionally, the audit team inspected crucial manufacturing stages, including the production of drug substances, downstream processing, conjugation, and quality control testing.

A Benchmark in Quality Assurance

Receiving the EU QP Declaration places Thousand Oaks Biologics' Shanghai facility among a select few contract development and manufacturing organizations (CDMOs) in China that can provide end-to-end international ADC services. This milestone serves as a testament to the facility's commitment to adhering to EU Good Manufacturing Practice (GMP) standards, regarded globally as a benchmark for pharmaceutical quality assurance.

Since its inception in 1975, the EU QP system has exemplified high standards, emphasizing the legal responsibilities for QPs during batch releases. The successful certification of Thousand Oaks Biologics not only highlights the quality capabilities of Chinese CDMOs but also aims to facilitate domestic ADC innovators' entry into global supply chains.

Implications for Future Operations

This validation not only strengthens Thousand Oaks Biologics' position in the competitive international biopharmaceutical market but also lays down a solid groundwork for advancing its ADC technology platforms. The company plans to enhance various aspects of its ADC processes, focusing on:

• - Conjugate Screening: Improving the selection and optimization of drug conjugates.
• - Process Development: Streamlining methods for more efficient production pipelines.
• - Purification Techniques: Increasing the purity and quality of ADC products.
• - Analytical Methods: Implementing advanced techniques for better monitoring and evaluation of product quality.

With the successful EU QP Declaration, Thousand Oaks Biologics will also focus on expanding its GMP-compliant manufacturing capacity tailored for both clinical trials and commercial drug products. Furthermore, they are poised to optimize production processes, manage changes effectively, and conduct rigorous product comparability studies, which will expedite their global business development initiatives.

By offering cohesive, high-quality services from the early stages of research and development to commercial manufacturing, Thousand Oaks Biologics remains dedicated to fostering the advancement and distribution of innovative therapies.

Conclusion

In conclusion, the EU QP Declaration awarded to Thousand Oaks Biologics is not just a certification; it represents a commitment to excellence and an inclination towards global standards in biopharmaceutical manufacturing. As the company augments its ADC technology capabilities and manufacturing infrastructure, it stands at the forefront of a dynamic industry, prepared to meet the global demand for cutting-edge therapeutic solutions.