By Courtney Morgret, Sr. Scientist III, Manufacturing Sciences, Purification; Sabra Hanspal, Sr. Scientist I, Manufacturing Sciences, Purification; and Evan Pasenello, Account Manager, Biologics
Antibody-drug conjugates (ADCs) are an important, emerging class of Biologics that exploit antibody specificity to achieve targeted delivery of a small molecule drug. In contrast to traditional small molecule drug products, which typically consist of pure chemical substances that are easily analyzed after manufacture, the complex structure of ADCs makes identification of clinically relevant components extremely difficult. For this reason, ADCs are defined by their manufacturing process, necessitating thorough process characterization to assure product efficacy and patient safety.
Because they afford such specific drug delivery, ADCs have significant potential to address unmet medical need and make a remarkable impact on patients’ lives. For this reason, ADC programs can accelerate rapidly from early to late stage clinical development. This highlights the importance of preparing for commercial launch early on to avoid incurring delays. Through careful planning of process/analytical development and characterization, commercial manufacturing site selection, and manufacturing-scale process performance qualification (PPQ), the introduction of an ADC to market can be expedited.
ADCs are widely recognized as newcomers to the biopharmaceutical marketplace, with just five products granted FDA approval to date. Yet with many more ADCs in the pipeline, a range of innovative technologies are currently under investigation to develop these drug products. Irrespective of the route chosen, it is essential that the associated manufacturing processes are well understood, scaled up, and fully optimized to support clinical and commercial demands throughout the entire ADC lifecycle. To reduce the risk of manufacturing failures and regulatory delays, it is sensible to partner with a CMO offering a strong Biologics foundation.