ADCs: Requirements in terms of GMP and occupational safety - PART 2 The challenges presented by a new generation of highly active pharmaceutical products for cancer treatment

ADCs (antibody drug conjugates) are a new generation of highly active pharmaceutical products used, among other things, in the targeted treatment of cancer. For health and safety reasons, most of these ADCs require containment in the double or triple-digit ng/m(3) range. Manufacturing ADCs is a new challenge, particularly in aseptic production. While isolators have been used successfully in this area for many years, they are now being called on to provide active personal protection as well. A contradiction in terms? At first glance, yes. While the aseptic process must be operated in positive pressure in accordance with GMP (Good Manufacturing Practice) requirements, personal protection isolators are typically operated in negative pressure in order to prevent the hazardous substance from escaping. Special seals on the isolator, innovative filter technology and a well-conceived pressure-cascade concept with active mouseholes make it possible to protect both product and personnel.