Intellective Bio's Suzhou Industrial Park GMP Manufacturing Site Passes EU QP Certification-Newsroom

In December 2022, Intellective Bio's manufacturing site in Suzhou Industrial Park successfully passed an audit by a European Union Qualified Person (QP), signifying that the quality system at Plant II was in full compliance with EU GMP requirements.

Audit Process

Due to COVID-19 impacts, this QP audit was conducted remotely. The EU QP auditor, Gábor Mihályi, conducted the assessment in accordance with EU GMP EudraLex Volume 4 and its annexes, US FDA, and PIC/S guidelines, covering the company's quality management system, production processes, quality control, aseptic processes, and product release. Following the audit, Gábor Mihályi highly praised Intellective Bio's facility infrastructure and quality management standards, while the staff's professionalism and rapid response also left a deep impression.

GMP Base Construction

Intellective Bio has currently established three sites compliant with Chinese, EU, and US quality standards, with a total capacity exceeding 200,000 L. The company's three production sites and supporting quality management systems have passed the EU QP certification, multiple on-site audits by global commercial partners, and several domestic Drug Manufacturing Licence inspections, demonstrating full compliance with various international standards.

The core equipment comprises imported high-end brands. Upstream, it includes Cytiva's 200 L, 500 L, 2000 L single-use bioreactors and 6000 L stainless-steel bioreactors. Downstream, it features Cytiva chromatography systems, providing production services for different project phases and quality requirements. The formulation line uses imported Watson-Marlow/BOSCH fillers, Tofflon lyophilisers, and automated loading/unloading systems. Components contacting the product directly use single-use technologies to avoid cross-contamination.

Intellective Bio consistently integrates rapid response with high-quality production, having established a world-class quality management system. The company has built a robust quality control platform for large-molecule drugs compliant with China and US filing requirements, alongside CMC teams for clinical and commercial stages. This ensures compliance with GMP requirements across different clinical trial phases and commercial products, guaranteeing consistent service quality and earning client trust.

Passing the EU QP audit is a significant recognition of Intellective Bio's quality management system and provides strong support for the company's global strategic layout. Moving forward, Intellective Bio will continue to expand its production capacity, refine its production quality management system and advance process technology development and application, offering stronger support for global clients' new drug R&D, aiming to bring the benefits of biopharmaceutical development to patients worldwide sooner.