Microbial Process Characterization and Validation
Benefit from our dedicated team experienced in late-stage projects to support process characterization and validation studies while delivering relevant documentation.
With you on your biologics journey...
Why do microbial process characterization and validation?
Process characterization forms part of a systematic approach of validating parameter control ranges for the production process.
Effective process validation significantly contributes to assuring drug quality. Therefore, it is crucial to prove that varying process conditions result in consistent quality based on a carefully defined set of specifications.
3P’s process characterization and validation services
Risk management system and Quality by design are the guiding principles following the product’s lifecycle and are the fundamental basis for process characterization and validation activities conducted by us.
We perform a risk assessment to guide subsequent activities, clearly defining which parameters need investigation. Critical quality attributes (CQAs) are linked to clinical safety and efficacy data and critical process parameters (CPP).
We perform a scale-down model of the process while varying the parameters defined as potential CPPs. The control strategy defined for the process is tested to evaluate each parameter’s criticality for its impact on the CQAs.
We conduct an intermediate stability study to provide documented evidence, so a selected number of process intermediates are stored for a pre-determined hold time. We also assess the stability of media, feeds and buffers.
Ultimately, CPPs are re-assessed in-house based on process characterization studies. The Normal Operating Range (NOR) of the process is positioned within the Proven Acceptable Range (PAR) for each CPP defined during the Process Characterization. For process validation activities, we assess process information and identify areas of remaining risk and prepare validation protocols. The validation runs are then executed at the setpoints of the process operating parameters.
What we will deliver
We have a dedicated team experienced in late-stage projects supporting process characterization and validation studies while providing you with the relevant documentation for inclusion in regulatory dossiers.