Process Characterization

Whilst developing a new biopharmaceutical product a manufacturing process will need to be developed that can be run to cGMP.  The critical quality attributes (CQAs) of the product will be decided and a process developed that can deliver on these attributes.  The process will be described and documented in detail to ensure that the CQAs can be met consistently to give a safe and efficacious product after every manufacturing run.

When developing a manufacturing process, intermediate products in the process will be tested at pre-determined points.  This to ensure that each step of the process is working as expected and that the process is operating within pre-defined operating parameters. At the end of the manufacturing run the final product will also be tested as part of its release.  As the manufacturing process is further refined and optimised as the product passes through the various phases of clinical trials, the process will be characterized using a battery of methods some of which are not performed during routine manufacturing as well as QC methods.  These characterization data can be used to understand the impact of process parameters and any changes to them upon the final product’s Critical Quality Attributes.  This allows a process control strategy to be defined that will be able to maintain consistent process performance.  This process understanding should also be linked to understanding how raw materials and reagents used in the process affect the final product.

GRA is experienced in helping clients characterize their processes in preparation for process validation exercises.  For biologics, it is becoming increasing common for processes to be validated prior to initiation of phase III clinical studies.  Therefore many organisations a performing process characterization during early development once the process is clearly defined.