Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) are biotherapeutics that consist of monoclonal antibodies (mAbs), potent cytotoxic drugs, and linkers between them. ADCs are part of a specialized subset of highly potent active pharmaceutical ingredients (HPAPIs), and compounding these drugs require strict compliance with standards, careful handling techniques and utilization of specialized equipment to provide operator, patient and environment protection.

There is a need to balance the conflicting handling requirements for the antibody and HPAPI components. The antibody and its final conjugated product require standard handling techniques regarding sterility which can be achieved under positive pressure to prevent entrance of particles and microbes. However, when dealing with highly potent compounds, because operations should be done under negative pressure to protect operators from exposure to these hazardous materials. To resolve this, HPAPI should be weighed and dissolved in an isolator located in a separate room while conjugation, purification and filling of the ADC can be safely done in other rooms under positive pressure. Airflow should be single-pass, unidirectional, to ensure that the air within the chamber meets required classifications.