Biomedical Engineering Reference
In-Depth Information
Prototype instruments of an ATP analyzer are described as a useful PAT tool
[
124
]. However, to my knowledge, not many analyzers have been sold and are in use.
Practically all immunoassays such as surface-based fluoroimmunoassays are
postprocess analyses and not online, despite being described as ''during cell cul-
ture'' (e.g., [
125
]); a similar statement holds true for protein and DNA chip
technologies [
126
].
4 Conclusions
Few new sensors and process analyzers have invaded production facilities in the last
decade, in spite of the PAT initiative of the FDA published 8 years ago. However, a
considerable improvement is obvious in the R&D process domain and in academia
over this time, although automation of laboratory techniques and use of automated
laboratory analyzers (as opposed to process analyzers) has proceeded at a much
faster pace and, obviously, brings much greater return on investment, because this
market is larger and healthcare oriented rather than technically focused. The
(commercially producing) biotechnology and pharmaceutical industry seems to be
conservative and very reluctant to implement these process analyzer tools, probably
because the potential benefits are not routinely investigated, evaluated, and dem-
onstrated, probably because of the short-sighted, shareholder-oriented manager
attitudes resulting in never-ending personnel and budget cuts.
References
1. Sonnleitner B (2000) Instrumentation of biotechnological processes. Adv Biochem Eng/
Biotechnol 66:1-64
2. Schuegerl K (2001) Progress in monitoring, modeling and control of bioprocesses during
the last 20 years. J Biotechnol 85(2):149-173
3. Carloni A, Turner APF (2011) Bioprocess monitoring. Encycl Ind Biotechnol 2:766-783
4. Junker BH, Wang HY (2006) Bioprocess monitoring and computer control: key roots of the
current PAT initiative. Biotechnol Bioeng 95(2):226-261
5. Duennebier G, Tups H (2007) FDA PAT Initiative—Eine Anwendersicht zu technischen
Möglichkeiten und aktueller industrieller Umsetzung. Chem Ing Tech 79(12):2019-2028
6. Clementschitsch F, Bayer K (2006) Improvement of bioprocess monitoring: development of
novel concepts. Microb Cell Fact 5:19
7. Julien C, Whitford W (2007) Bioreactor monitoring, modeling, and simulation. BioProc Int
5(1):10-17
8. Glassey J, Gernaey KV, Clemens C, Schulz TW, Oliveira R, Striedner G, Mandenius CF
(2011)
Process
analytical
technology
(PAT)
for
biopharmaceuticals.
Biotechnol
J
6:369-377
9. Vojinovic V, Cabral JMS, Fonseca LP (2006) Real-time bioprocess monitoring. Part I: in
situ sensors. Sens Actuator B 114(2):1083-1091
10. Olsson L, Schulze U, Nielsen J (1998) On-line bioprocess monitoring—an academic
discipline or an industrial tool? Trends Anal Chem 17(2):88-95
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