Biomedical Engineering Reference
In-Depth Information
Process flow for
commercialization
Process flow for
characterization
Decision to
Risk analysis
commercialize
Commercial process
Scale-down model
development and
optimization
definition and
qualification
Process
DOE studies
characterization
Process validation and
Worst-case studies
process monitoring
Definition of design
Regulatory
space*
submission
Definition of
Approval and product
validation
acceptance criteria
launch
Figure
5.1. Overall process flow chart for commercialization of a biological product.
The location of the process characterization subprocess is indicated.
*
After limits for critical
product quality attributes are defined.
elucidate how the above-mentioned approach to process characterization can be
followed for defining process design space.
5.3 RISK ANALYSIS
FMEA is a risk assessment tool widely used in the biotech industry for its underlying
rigorous methodology for evaluating, prioritizing, and documenting potential failures
of process and product performance [6]. In this case study, FMEAwas used as a tool for
prioritizing operational parameters for process characterization studies based on
process knowledge. This approach involves assessment of operational parameters by
