By Evan Pasenello and Daniel Sayut
While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. Not only does this make their production considerably more challenging, but it also means that identification of clinically active components is extremely difficult. Because of this, biologics are instead defined by their manufacturing process, which requires complete understanding through formal process characterization.
Typically carried out during the late stages of drug development, following phase II clinical trials, process characterization is an essential component of process validation. Providing an in-depth understanding of a drug product to establish effective process control strategies, process characterization helps to define the critical product and process parameters and determine the proven acceptable ranges for efficient manufacturing. Without thorough and comprehensive testing data a biologics license application (BLA) for the manufacture of a biopharmaceutical for commercial distribution will invariably be denied by regulatory bodies such as the US FDA.
Read how AbbVie’s five-step process results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale, and since it is much harder to implement changes post- commercialization, continued process validation is employed.