Telitacicept
Disitamab Vedotin
Product Pipeline
Production and Manufacturing
We have leading manufacturing facilities with global GMP standards to meet the clinical and commercial production requirements of our pipeline, our manufacturing facility currently houses six 2000L disposable bioreactors and we have the competitive strength of scale production of a variety of innovative biological pharmaceutical products. Meanwhile, we are building new production facilities.
Quality Assurance
RemeGen has integrated production capacities to produce monoclonal antibodies, fusion proteins, antibody-drug conjugates, bifunctional antibodies and other complex molecules. Its factory buildings and the ancillary facilities have reached world leading. We have built a professional quality assurance team led by medical professionals with decades of biopharmaceutical development experience in Europe or the United States. We have been focused on building a quality management system that meets the international standards to expand our global outreach. RemeGen have established the quality policy of Making Medicines With Integrity, Scientific Management,Continuous Improvement and Pursuit of Excellence. We shall build a quality management system that meets the GMP requirements of FDA, EMA and NMPA.
