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 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.

Our dedicated team of specialists will be happy to discuss any of your SERVICE needs. Contact us on +34 948 346 480 or email businessdevelopment@3pbio.com

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

  • It’s about our capacity and how we visualize and invest in the processes it takes to grow with you. An infrastructure built on an unmatched and shared commitment to ensuring your biologics journey makes a difference to those who need it.

Get in touch

Let’s discuss your biologics journey.

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