ACKNOWLEDGEMENTS
The authors extend their appreciation to Rohini Deshpande and Gang Xue
for their invaluable inspiration, strategic guidance, and managerial
support in the development of the µSI process analyzer and the A2P2
systems. We acknowledge Neil Soice and Nitin Rathore for their guidance
from the Drug Substance and Drug Product perspectives in our PAT
projects. Our gratitude goes to Alicia Zeng for her pioneering work at
AMA (Amgen Massachusetts), where she implemented the µSI process
analyzer for real-time MAM data collection from a production bioreactor.
We also express our gratitude to the ATO (Amgen Thousand Oaks) Rapid
Analytics team members Eleanor Le, Jennifer Zapparelli, Danielle
Borchard, and Miranda Hutt for their assistance during the A2P2 system’s
comparability testing phase. Gary Li, Da Ren, and Jason Richardson are
acknowledged for their strategic and technical input during the early
phase of A2P2 development for MAM, alongside Tom Dillon for his
expertise in LC software operation, which improved our understanding of
the SST and IRC algorithms.