Manufacturing antibody-drug conjugates (ADCs) is a complex process with requirements that change frequently. As highly toxic substances are being processed and batch values are very high, ensuring operator safety and product integrity is a critical prerequisite. Additionally, the transition and scale-up to commercial manufacturing introduce the challenges of investment cost and training efforts.
ADC manufacturing typically occurs in multi-use setups due to the presence of solvents and high pressures, raising concerns surrounding the ability of plastic containers to withstand these harsh conditions. Consequently, transferring an ADC process to single-use (SU) setups presents a formidable challenge. The data presented here demonstrates the ability of the Sartoflow® Expert SU to meet the specific needs of ADC processes, including required solvent resistance, safety concepts, and automation. This success enables ADC manufacturers to leverage the convenience offered by SU applications, streamlining processes by eliminating time-consuming steps like sanitization, flushes, and validations, while still maintaining the high performance associated with multi-use unit operations.