Mercachem offers GMP production of drug substances for clinical trials and materials for commercial use on up to a 3 kg scale. Our experienced team has a long track record in production of small-molecule active pharmaceutical ingredients (APIs) and drug-linker conjugates for antibody–drug conjugate (ADC) products, based on ICH QA7 quality management guidelines.
The seamless integration of process optimization, (non GMP) validation, and GMP production, all within the walls of Mercachem, assures a smooth transfer of technology.
Are you looking for control over all aspects of production, including materials, equipment, personnel, and documentation? We are ready to take your project to the next stage in our FDA-inspected GMP production facilities.