Putting The "Process" Into Process Characterization

Before you can validate your process, receive regulatory approval, and manufacture a biopharmaceutical for commercial distribution, the critical step of Process Characterization provides the in-depth understanding of the drug product to establish effective process control strategies. The experiments and studies performed during Process Characterization help define the critical product and process parameters and determine the proven acceptable ranges for efficient manufacturing.  

Done correctly, Process Characterization reduces the risk of manufacturing failures and regulatory delays. Though it requires a significant investment of time and resources, it provides a level of confidence in the successful manufacture of complex biologic products.

Currently, there are no industry standards or firm guidelines around Process Characterization. Pharmaceutical companies and CMOs establish their own processes based on experience and benchmarking against industry peers.

Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to Process Characterization that has been proven effective as it has been used to support the approval of several marketed products. AbbVie has mapped out a five-step process that results in a thorough understanding of the biologic and process control strategies to ensure drug safety, purity, and potency at the commercial scale. Process Characterization efforts continue throughout commercial manufacturing, to continually assess, refine, and improve processes.