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Process Validation

Process validation is the collection and evaluation of data, from the process design stage through commercial production, to establish scientific evidence that a production process is capable of consistently delivering a product.

Successful process validation is a regulatory prerequisite for commercial approval of biologics and an essential element in the assurance of drug quality. For late-stage projects we offer process validation meeting all regulatory requirements. Working together with our clients, we develop the best path to highest product quality as well as reliable and consistent future product supply.

We distinguish three stages in the life cycle of the process validation:

Process design and characterization
Process (performance) qualification
Continued process verification

Process design and characterization

WACKER has extensive platform knowledge and hands-on experience in performing process characterization of biopharmaceuticals. Several processes have been successfully characterized and validated at Wacker Biotech, including ones for recombinant proteins, vaccines and plasmid DNA.

Wacker Biotech develops, characterizes and validates the manufacturing process in accordance with EU requirements as defined in ICH Q8 to Q11. The BioProcess Development department is equipped to perform comprehensive process development and characterization activities. The procedures ensure reproducible process performance and consistently high product quality.

Our services include among others:

Definition of the process design space by evaluating critical process parameters and developing a process control strategy as requested by Quality by Design (QbD) guidance
Robustness studies at laboratory scale
Characterization of impurity profile (process and product related substances)
Column life cycle study for each chromatography step

As a result, controls are defined that include:

Parameters and attributes related to drug substance and drug product
Quality risk assessment (FMEA)
Materials and components
Facility and equipment operating conditions
In-process controls
Finished product specifications
Methods and frequency of monitoring and control

8 x 15 L Biostat bioreactors for upstream process characterization.

Process (performance) qualification

The process qualification program is based on the process characterization report and the corresponding risk analysis. PPQ batches are deemed to be sufficient for process qualification and to demonstrate consistency. The process and the control strategy developed during first stage Process Design and Characterization are tested in this stage. Our experts evaluate the capability of the manufacturing process to consistently manufacture a product meeting all required quality attributes.

Our services include among others:

Quality risk assessment (FMEA)
Process performance qualification (PPQ) batches
Validation of analytical methods
API shipping validation
API freeze / thaw studies
Extractables & leachables studies
Intermediate hold time study (at scale)
Resin lifetime studies
Impurity clearance studies
Cleaning validation
Bulk fill homogeneity studies
End-of-Production cells studies
Mixing validation studies
Container closure integrity test
Aseptic process simulation

Continued process verification

Continued process verification is the 3rd stage of process validation. In this stage, relevant information on product and process performance and consistency is compiled and evaluated at defined intervals.

Our services include among others:

Continuous evaluation of critical quality attributes (CQAs), in-process-controls (IPCs), critical process parameters (CPPs) and key process parameters
Identification of process trends or drifts using data visualization and statistical tools
Identification of potential for further process understanding and process improvements by introducing additional monitoring techniques