As the biopharmaceutical industry continues to advance its methods of treating disease, novel drug delivery systems are being developed to target specific areas in a patient as opposed to administering treatment systemically. For example, in the case of antibody drug conjugates (ADCs), the cytotoxic cancer drug is conjugated to the antibody so that it can be received by the tumor only and not the rest of the body. This reduces the harmful side effects to the patient while also increasing the drug’s efficacy. The formulations for these types of drug delivery systems are complex and therefore present challenges regarding the stability, efficacy, potency, and even safety of drug products during clinical and commercial phases. Often, the implementation of specialized equipment and/or processes is necessary to ensure successful formulation.
This article discusses six major types of complex formulations as well as the important equipment and processes necessary to develop GMP-compliant processes. Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development in order to achieve successful scale-up and manufacturing.