Ruud Verstegen is Process Engineer downstream processing at Byondis, creator of precision medicine. At the Single Use Event 2023, he will speak on the manufacturing of antibody-drug conjugates using single-use materials and its pros and cons.
Antibody–drug conjugates (ADCs) are biopharmaceuticals consisting of a monoclonal antibody linked with a highly potent cytotoxic drug. The purpose of the antibody is primarily to target the drug to receptors on tumor cells and secure internalization while the function of the cytotoxic drug is to kill the targeted tumor cells.
A major focus during the manufacture of ADCs is protecting a product from contaminants in the environment of a production facility but also the protection of employees within that environment from exposure to what can be very hazardous substances. While the use of glass or stainless-steel systems may effectively protect operators, significant equipment decontamination and cleaning validation is required. As an alternative, single –use technologies offer specific benefits but also come with challenges.