Hurdles in safe handling of ADCs
The production of ADCs call for cGMP-compliant aseptic environments that are to ensure containment of the highly toxic drug compounds. This is to ensure that the drug products are both
- consistently efficacious and
- safe from cross-contamination or bioburden
Not only are these requirements governed by rigorous administrative and quality standards but they present significant operational challenges.
The processing and handling of substances and molecules such as monoclonal antibodies and toxic payloads calls for a multi-disciplinary approach. In order to allow for streamlined sterile filling and aliquoting, equipment that is versatile and compatible with various needs is indispensable.
The entire filling process must be validated. This includes validation of the equipment, the environment, and the process itself.
Apart from ensuring a clean environment that is free from bioburden, all primary packaging, such as single-use bioprocess containers, must be sterilized. This can be achieved by autoclaving or gamma irradiation.
When utilizing single-use technologies, however, manufacturers and CMOs can dispense with these processes, because all components are supplied sterilized. This means that time-consuming and cost-intensive cleaning or sterilization processes are no longer required.