Process Characterization / Process Validation

KBI's Approach to Process Characterization & Process Validation Services

Process Validation: ”Collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
Guidance for Industry - Process Validation: General Principles and Practices, January 2011

Presentation | Quality by Design at a Biopharma CMO

Process Validation is a lifecycle of activities consisting of the following stages:

Stage One (1a & 1b): Process Design
Using product and process knowledge gained during development and scale-up activities to define the commercial process and control strategy.

Learn More About Process Design

Stage Two: Process Qualification
A formal study with the aim of confirming that the commercial process is capable of reproducibly producing product meeting pre-defined acceptance criteria at-scale.

Learn More About Process Qualification

Stage Three: Continued Process Verification
Systematic program established to ensure that the commercial process remains in a state of control.

Learn More About Continued Process Verification

KBI performs these late-stage process characterization and scale-down validation studies as a stand-alone package to support late-stage process development and commercialization from a client’s manufacturing plant or from KBI’s manufacturing plant. KBI also supports PAI (pre-approval inspections) and other regulatory inspections needed for product approval.