Biomedical Engineering Reference
In-Depth Information
Figure
12.12.
Monitoring UV elution profiles versus transition analysis results [36].
shown in Fig. 12.13) provides an effective and sensitive means of detection of adverse
trends in column integrity changes that mayleadtoprocessupsetsandproductquality
issues [36].
12.9 CHALLENGES FOR IMPLEMENTATION OF PAT TOOLS
12.9.1 Organizational Structure
The challenges of implementing PAT in bioprocess manufacturing is always sure to elicit
vigorous discussion and debate within any biotechnology company involved in a PAT
initiative. In terms of governance, typically, a hierarchical matrix structure exists within
biologic manufacturing organizations. The matrix consists of individual PAT project
teams, a project governance committee, and an executive governance board. The teams
are generally made up of a group of employees operating cross-functionally. They are
responsible for identifying the process problem (or improvement opportunity), brain-
storming on possible solutions, designing and performing a proof-of-concept study to
test out the potential PAT tool, risk assessment, and finally bringing it to the governance
committee for discussion, review, and decision making as to whether the project should
be advanced (go/no-go). The governance committee typically consists of senior man-
agement personnel from process development, manufacturing, and quality that assess a
project's merit and determine if the technology is better suited for implementation in the
