Antibody drug conjugate manufacture
ADC products consist of three compounds which are combined through bioconjugation techniques:
- a monoclonal antibody
- a payload or cytotoxic drug and
- a stable linker.
Through the combination of the tumor targeting quality of the monoclonal antibody and the drug, it becomes possible to deliver effective cytotoxins directly to cancer cells without the risk of damaging healthy ones.
The steps to manufacture ADCs each bear their own challenges.
MAb production and characterization is an important step in the successful outcome of ADC production. The antibody needs to have specific binding qualities to recognize the cancerous cells and deliver the drug to its target. mAbs are sensitive protein structures which are prone to contamination and product loss during production. To produce them on a large-scale the right equipment and expertise is needed.
The same can be said for the drug development and bioconjugation through a drug-linker. There are many details which have to be considered before an ADC enters the market.
ADCs are a novel solution for cancer or autoimmune diseases and its market is growing. Many ADCs are currently in preclinical development or in ADC clinical trials waiting for their FDA approval, as well as many assays in validation.
In most cases different parties and departments are involved in the production and these steps are carried out by different biopharmaceutical manufacturing services as they require specific equipment, manufacturing environments and in-depth knowledge. Due to this instance, it is often necessary to transport ADC bulks from one manufacturing facility to another.
To provide safe handling of ADCs it is important to decrease risk of product loss through breakage, of temperature deviations at ultra-low temperatures and of disruptions of the supply chain. To make this possible, they have to be kept at -80 degrees.