Challenges in the development and manufacturing of antibody-drug conjugates.

Advances in antibody-drug conjugates (ADCs) will permit sensitive discrimination between healthy and cancer cells. Promising clinical results generated much hope that this targeted prodrug therapy will offer more effective treatment options to patients. Manufacturing such highly potent biopharmaceuticals presents a series of unique challenges. Some specific skills required for the process development and production of ADCs are discussed. In addition to the accuracy and reliability needed to handle these potent and costly materials, coworker safety and equipment cleaning are of particular importance. The ideas and concepts shared in this article are based on the experience that Lonza has gained in the ADC field since 2004.