MabPlex International, Ltd. (“MabPlex”), a leading global CDMO specializing in Antibody-Drug Conjugates (ADCs) and biologics, is pleased to announce the successful completion of its fourth European Union Qualified Person (EU QP) on-site audit.
This accomplishment marks the company’s second dedicated audit specifically for ADC projects and serves as a critical validation of MabPlex’s robust quality management systems and its readiness to support large-scale commercialization for the global market.
De-risking the ADC Supply Chain
For VPs of External Manufacturing, the primary challenge in the current market is the scarcity of end-to-end, commercially ready ADC capacity. MabPlex addresses this gap by providing a seamless, integrated platform that encompasses the entire value chain: from R&D and monoclonal antibody production to linker-payload synthesis, conjugation, and sterile fill-finish.
The successful EU QP audit, conducted in strict accordance with EU GMP standards, focused on high-stakes operational areas including:
- Aseptic Assurance & Containment: Critical for high-potency ADC manufacturing.
- Data Integrity & Computerized Systems: Ensuring seamless regulatory filings for the EMA and FDA.
- Material Management: Guaranteeing traceability across complex global supply chains.
Proven Market Leadership and Execution
MabPlex’s reputation as a specialized ADC expert is backed by industry-leading metrics that demonstrate both scale and reliability:
- Market Dominance: MabPlex provides core CMC support for nearly 30% of all ADC clinical approvals in the region, one of the world’s most active biopharma hubs.
- Proven Track Record: To date, the company has secured more than 30 global clinical approvals for ADC projects.
- Regulatory Maturity: Since 2016, MabPlex has successfully navigated over 270 inspections and audits from global clients and regulatory bodies, consistently achieving satisfactory outcomes.
- Commercial Readiness: With the first ADC product serviced by MabPlex expected to receive marketing approval in 2027, the infrastructure is already in place for large-scale, post-approval commercial supply.
A Stable Partner for Global Expansion
In an era of shifting geopolitical dynamics, MabPlex remains committed to being a stable, transparent, and globally-compliant partner. Our quality management system is built upon international benchmarks, including ICH Q10, FDA cGMP, EMA GMP, and PIC/S GMP, ensuring that our partners’ intellectual property and regulatory pathways are protected at every stage.
By leveraging advanced isolator technology and high-performance synthetic process laboratories, MabPlex provides the technical sophistication required by the world’s leading biologics companies to bring life-saving ADC therapies to patients faster and with lower regulatory risk.
Connect with Our Strategic Partnership Team
As you evaluate your external manufacturing footprint for 2026 and beyond, we invite you to discuss how MabPlex’s end-to-end ADC capacity can secure your clinical and commercial milestones. Contact us on [email protected] to schedule a technical briefing or a virtual facility tour.
