Process Execution in the A2P2 System
The aim of creating the
autonomous workflow in Figure 5 is to illustrate the A2P2
system’s ability to conduct a lengthy laboratory process autonomously
while eliminating the need for an analyst’s input: titer measurement for
the starting material, affinity purification for the starting material,
titer measurement for the purified sample, and subsequent PQ analysis,
in this case, the protein aggregation assay. This workflow serves as a
foundation for independent operation of all applications documented in
this paper, as well as for future A2P2 uses. The System Suitability
Testing (SST) and Intelligent Run Control (IRC) functions are applied in
concert, automating the process of sample coordination, operating
parameter generation, and transfer among the A2P2 system actions. This
substantially reduces human involvement, mitigates transcription errors,
enhances assay reliability, and accelerates the decision-making process.