Mabwell has established an advanced R&D system which covers target discovery, early discovery, druggability, preclinical, clinical research and manufacturing transformation. The International Standard Drug Discovery Platforms and Skillful & Efficient Development Platforms enable us to develop innovative biologics efficiently and submit IND rapidly. We put emphasize on large-scale, fast-growing therapeutic areas including auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases, etc. Mabwell has 17 pipeline products. Of these, 1 product has been approved and commercialized, 2 products have been filed for MA approval, 3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development", 2 projects for National Key R&D Programmes, and multiple provincial and municipal science and technological innovation projects.
We operate our manufacturing sites under Good Manufacturing Practice (GMP) standards adopted by the U.S. Food & Drug Administration (FDA), the China National Medical Products Administration (NMPA), and the European Medicines Agency (EMA).
Our facilities have drug substance production lines with disposable bioreactors and stainless steel bioreactors, and drug production filling lines for pre-filled syringes and vials in multiple specifications.
69,700 m²
Annual production capacity: 27,000L (first phase project).
Advanced & efficient digital process management serving global market.
EU QP Audit passed.
Antibody production capacity of 4,000L, which can be expanded to 8,000L. Fusion protein production capacity of 4,000L.
The 53,400-square-meter Large Scale Commercial Manufacturing Site (under construction) will be used for the production of ADC & recombinant protein.
