Biomedical Engineering Reference
In-Depth Information
6. Hans J, Bansal A (2009) Biopharmaceutical information infrastructure 2.0. BioProcess Int
7(11):10-19
7. ICH
Harmonised
Tripartite
Guideline:
Q8(R1)
Pharmaceutical
Development
(2008)
http://www.ich.org/LOB/media/MEDIA4986.pdf
8. ICH
Harmonised
Tripartite
Guideline:
Q9
Quality
Risk
Management
(2005)
http://www.ich.org/LOB/media/MEDIA1957.pdf
9. ICH
Harmonised
Tripartite
Guideline:
Q10
Pharmaceutical
Quality
System
(2008)
http://www.ich.org/LOB/media/MEDIA3917.pdf
10. Kirdar AO, Connor JS, Baclaski J, Rathore AS (2007) Application of multivariate analysis
toward biotech processes: case study of a cell-culture unit operation. Biotechnol Prog 23:61-67
11. Konold P, Woolfenden R II, Undey C, Rathore AS (2009) Monitoring of biopharmaceutical
processes: present and future approaches. BioPharm Int 22(5):26-39
12. Kozlowski S, Swann P (2009) Considerations for biotechnology product quality by design.
In: Rathore AS, Mhatre R (ed) Quality by design for biopharmaceuticals: perspectives and
case studies. Wiley, New Jersey, pp 9-30
13. Martin EB, Morris AJ (2002) Enhanced bio-manufacturing through advanced multivariate
statistical technologies. J Biotechnol 99:223-235
14. Nucci ER, Cruz AJG, Giordano RC (2010) Monitoring bioreactors using principal component
analysis: production of penicillin G acylase as a case study. Bioprocess Biosyst Eng 33:
557-564. doi: 10.1007/s00449-009-0377-y
15. PAT Guidance for Industry—A Framework for Innovative Pharmaceutical Development,
Manufacturing and Quality Assurance (2004) US Department of Health and Human Services,
Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER),
Center for Veterinary Medicine (CVM), Office of Regulatory Affairs (ORA)
16. Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (2008) Code of
Federal Regulations, Title 21, vol 4, US Department of Health and Human Service, Food and
Drug Administration (FDA)
17. Rathore
AS
(2009)
A
roadmap
for
implementation
of
quality
by
design
(QbD)
for
biotechnology products. Trends Biotechnol 27:546-553
18. Rathore AS, Winkle H (2009) Quality by design for pharmaceuticals: regulatory perspective
and approach. Nat Biotechnol 27:26-34
19. Rathore AS, Parr L, Dermawan S, Lawson K, Lu Y (2010) Large scale demonstration of
process analytical technology (PAT) in bioprocessing: use of high performance liquid
chromatography (HPLC) for making real time pooling decisions for process chromatography.
Biotechnol Prog 26:448-457
20. Undey C, Tatara E, Cinar A (2003) Real-time batch process supervision by integrated
knowledge-based systems and multivariate statistical methods. Eng Appl Artif Intell 16:
555-566
21. Undey C, Ertunc S, Cinar A (2003) Online batch/fed-batch process performance monitoring,
quality prediction and variable contributions analysis for diagnosis. Ind Eng Chem Res
42(20):4645-4658
22. Undey C, Tatara E, Cinar A (2004) Intelligent real-time performance monitoring and quality
prediction for batch/fed-batch cultivations. J Biotechnol 108(1):61-77
23. Ündey C, Ertunc S, Mistretta T, Looze B (2010) Applied advanced process analytics in
biopharmaceutical manufacturing: Challenges and prospects in real-time monitoring and
control. J Process Control 20:1009-1018
24. Yoo CK, Lee IB (2006) Nonlinear multivariate filtering and bioprocess monitoring for
supervising nonlinear biological processes. Process Biochem 41:1854-1863
Search WWH ::




Custom Search