Process Development: Maximizing Process Data from Development to Manufacturing - - BioPharm International

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Process Development: Maximizing Process Data from Development to Manufacturing


BioPharm International
Volume 20, Issue 7

Claire Hill is a bioprocess engineer at BioPharm Services UK, Lancer House, East Street, Chesham, Bucks, HP5 1DG, United Kingdom, +44 (0) 1494.793243,

Andrew Sinclair is cofounder and managing director at BioPharm Services UK, Lancer House, East Street, Chesham, Bucks, HP5 1DG, United Kingdom, +44 (0) 1494.793243,

REFERENCES

1. Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nature Reviews Drug Discovery. 2003;2(9):695–703.

2. Morris K, Venugopal S, Eckstut M. Making the most of drug development data. PharmaManufacturing 2005 Nov 30;4(10):16 –23.

3. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: New estimates of drug development costs. J Health Econ 2003;22(2):151–85.

4. American National Standards Institute/Instrumentation, Systems, and Automation Society (ANSI/ISA). ANSI/ISA-88.01–1995 Batch Control Part 1: Models and terminology. Research Triangle Park, NC; 1995.

5. American National Standards Institute/Instrumentation, Systems, and Automation Society (ANSI/ISA). ANSI/ISA-88.00.03–2003 Batch Control Part 3: General and site recipe models and representation. Research Triangle Park, NC; 2003.


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