PAT is a useful paradigm and is making inroads into the biopharmaceutical industry, but the speed of acceptance has lagged
behind other industries, including typical pharmaceuticals. This delay in acceptance is unfortunate because PAT initiatives,
which are designed to develop a deeper understanding of the process and to control variability, could benefit biopharmaceuticals
more than any other industry because biological systems are so inherently variable. NIR and other analytical tools required
for this process understanding and variability control are already in place in other industries and will fit very well in
all stages of biopharmaceutical manufacture. FDA encourages the use of these tools in a well-designed PAT process, and their
use will reduce the time of manufacture and costs of reprocessed or out-of-specification product.
Todd Strother, PhD, is an applications scientist in the Scientific Instruments Division, Analyzer Group, at Thermo Fisher Scientific, 5225-4
Verona Road, Madison WI 53711, tel. 608.276.5626, email@example.com
1. FDA, Guidance for Industry PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance (Rockville, MD, Sept. 2004),
2. H. Trautman, "PAT in Bioprocessing," BioWorld EUROPE, 6–9 (2005).
3. J. Ganguly and G. Vogel, "Process Analytical Technology (PAT) and Scalable Automation for Bioprocess Control and Monitoring—A
Case Study," Pharm. Engin.,
26 (1), 1–9 (2006).
4. "Slow Adoption of PAT for Bioprocessing," Gen. Eng. & Biotechnol. News, 26 (16), (Sept. 15, 2006).
5. FDA, Center for Biologics Evaluation and Research Current Licensed Establishments and Products (Rockville, MD), Feb. 28,
http://www.fda.gov/cber/ep/part3.htm, accessed April 8, 2009.
6. D.L. Fernandes, "Biopharmaceutical Sialylation," Euro. Biopharm. Rev., Spring, 100–104 (2006).
7. J.A. Lopes et al., "Chemometrics in Bioprocess Engineering: Process Analytical Technology (PAT) Applications," Chemomet. and Intell. Lab. Systems, 74 (2), 269–275 (2004).
8. Y. Ozaki and T. Amari, "Near-Infrared Spectroscopy in Chemical Process Analysis," in Spectroscopy in Process Analysis,
J. Chalmers, Ed. (Sheffield Academic Press, 2000), pp. 53–92.
9. C. Card et al., "Near-Infrared Spectroscopy for Rapid, Simultaneous Monitoring of Multiple Components in Mammalian Cell
Culture," BioProcess Inter.,
6 (3), 58–67 (2008).
10. P. Roychoudhury et al., "Multiplexing Fibre Optic Near Infrared (NIR) Spectroscopy as an Emerging Technology to Monitor
Industrial Bioproceses," Analytica Chimica Acta,
590 (1), 110–117 (2007).
11. J. Hirsch, "Near-Infrared Analysis of Critical Parameters in Lyophilized Materials," BioPharm Inter.,
19 (2), 32–36 (2006).
12. T.P. Lin and C.C. Hsu, "Determination of Residual Moisture in Lyophilized Protein Pharmaceuticals using a Rapid and Non-invasive
Method: Near Infrared Spectroscopy," J. Pharm. Sci. Technol.
56 (4), 196–205 (2002).