Quality Management Overview

Our international standard quality management system guarantees your successful drug development from early development, preclinical material production, to final commercial production.

Along with the establishment of the quality management system in accordance with GMP standards, MabPlex has built world-class facilities and laboratories to satisfy our partner’s needs. Our quality department sets up and maintains MabPlex’s GMP quality system, regulating the biopharmaceutical production process, and managing production quality control to ensure compliance with the latest US FDA, EMA, and Chinese FDA (CFDA) regulatory requirements.

Based on the Quality by Design (QbD) concept, MabPlex’s cutting-edge quality analysis technology platform utilizes an array of critical analytical techniques including high throughput and sensitive instruments such as mass spectrometry and capillary electrophoresis. Our world-class quality management system and analysis techniques guarantee the high quality of our partner’s biological drugs. MabPlex’s quality management team has accumulated extensive experience in R&D, quality analysis, quality management, and commercialized biopharmaceutical production.

Our quality department consists of Quality Control (QC) and Quality Assurance (QA) with designated professionals for biological drug stability studies and storage under GMP requirements.