Downstream Process Optimization Opportunities Using On-Line and At-Line PAT Instrumentation - Technologies for downstream process applications continue to emerge as the PAT initiative is fully impleme

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Downstream Process Optimization Opportunities Using On-Line and At-Line PAT Instrumentation
Technologies for downstream process applications continue to emerge as the PAT initiative is fully implemented into biotechnology manufacturing.


BioPharm International


References

1. http://www.fda.gov/cder/OPS/PAT.htm

2. PAT definition per FDA CDER. A system for designing, analyzing, and controlling manufacturing through timely measurements (during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. It is important to note that the term analytical in PAT is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner.

3. Sharaf MA, Illman DL, Kowalski B. Chemometrics. John Wiley and Sons; 1986.

4. Brereton RG. Chemometrics: Data Analysis for the Laboratory and Chemical Plant. John Wiley and Sons; 2003.

5. Brereton RG. Chemometrics and PAT. PAT Journal. 2005 2 (3) 8-11.

6. Willis RC. PAT Pending. Modern Drug Discovery. 2004 December.

7. Cooley RE. Utilizing PAT to Monitor and Control Bulk Technology Processes. Eli Lilly and Co. University of Michigan Pharmaceutical Engineering Seminars. 2003 March 4 .

8. On-line sampling systems for biotechnology applications are supplied by Groton Biosystems, YSI Instruments, and Nova Biosystems, among others.

9. Groton Biosystems GPA1000 Process Analyzer.


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