Biomedical Engineering Reference
In-Depth Information
an incentive to develop this technology further. It has the potential to provide real-time
information about growth kinetics and stoichiometry when harnessed with appropriate
chemometric tools.
Another area ripe for further development is further automation of flow injection
analysis for biopharmaceutical purification skids as a means for real-time feedback
loops. Since purification step runs are generally measured in hours, a simple and rapid
technique for quality attribute assessment in a 2 min time frame may allow implemen-
tation of these technologies in future purification processes.
In the arena of formulations, technologies that enable relevant time analysis of
compounding steps, loss on terminal filtration and loss on drying, should be investigated.
For facilities and plant monitoring, built-in analytical redundancy and tools such as
acoustic spectroscopy to measure the health of unit operation components in a plant
should be further explored. Data infrastructure improvements need to bemade that should
include further cross-industry harmonization on unified connectivity language, such as
AniML (analytical mark up language) and OPC (open connectivity) for plant and
analytical instrumentation to allow data modeling and process control implementations.
While some practitioners of PAT may yearn for more immediacy, the process of
adopting PAT will likely follow the timeline of getting a new drug approved. As most
scientists, engineers, and managers in the biotechnology have experienced, the
drug development process leading to filing of a Biologics License Application, this
can take 5-10 years. Many biopharmaceutical companies are reluctant to implement
these tools in existing commercial processes for fear of putting their revenue stream at
risk. Rather, implementation of these tools will more likely be a gradual process and be
put in place as new processes are developed.
ACKNOWLEDGMENTS
MichaelMolonywould like to acknowledge his former colleagues at Biogen Idec,Marissa
Braganza, Eddie Rustandi, Yao-Ming Huang, Eric Rosemyer, Maureen Lanan, Mia
Kiistala, KipLowery, AlimeKirdar, DamianHoude, JustinMcCue, Shefal Parikh,Mylene
Talabardon, Kelly Wiltberger, Robin Hyde-Deruysher, Joydeep Ganguly, Michael
Villacorte, Mahalia Ong, Soheil Rhamati, Valerie Tsang, Rohin Mhatre, Jorg Thommes,
David Chang, and Thomas Ryll, as well as a current colleague fromAllergan, Ron Bates,
who graciously provided editorial services; and finally, his collaborators Jun Park, Kurt
Brorson, Bob Mattes, Rick Cooley, George Barringer, and Mel Koch.
Cenk Undey would like to acknowledge his former colleagues at Amgen, Hiren
Ardeshna, Roderick Geldart, Asti Goyal, Wenshan Lee, Marty Martin, Julie Matthews,
Jay Stout; at FDA, Ali Afnan; his current collaborators andmanagement at Amgen, Sinem
Ertunc, Manuj Pathak, Katherine Chaloupka, Erin Collins, Sourav Kundu, Thomas
Mistretta, James Stout, Douglas Inloes, Dane Zabriskie, Kimball Hall, Tony Pankau,
Chris Bush, Marion Baust-Timpson, Sean Kelly, Alice Gardiner, Letha Chemmalil,
Steven Hunt, Robert McInerney, Larry Cater, Scott Kendra, Jayne Morris, Alex Lee,
Chris Vales, DenizBac, SethMoye, Murali Pasumarthy, DuncanLow, and Joseph Phillips.
Finally, thanks to Fetanet CeylanUndey ofAmgen for her support and editorial comments.