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Items: 1 to 20 of 112

1.

Development and characterization of a cell culture manufacturing process using quality by design (QbD) principles.

Marasco DM, Gao J, Griffiths K, Froggatt C, Wang T, Wei G.

Adv Biochem Eng Biotechnol. 2014;139:93-121. doi: 10.1007/10_2013_217.

PMID:
23828505
2.

Product quality considerations for mammalian cell culture process development and manufacturing.

Gramer MJ.

Adv Biochem Eng Biotechnol. 2014;139:123-66. doi: 10.1007/10_2013_214. Review.

PMID:
23748351
3.

Safety assurance for biologics manufactured in mammalian cell cultures: a multitiered strategy.

Chen D.

Adv Biochem Eng Biotechnol. 2014;139:167-83. doi: 10.1007/10_2013_213.

PMID:
23719711
4.

Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein.

Looby M, Ibarra N, Pierce JJ, Buckley K, O'Donovan E, Heenan M, Moran E, Farid SS, Baganz F.

Biotechnol Prog. 2011 Nov-Dec;27(6):1718-29. doi: 10.1002/btpr.672. Epub 2011 Sep 21.

PMID:
21948302
5.

Equipment for large-scale mammalian cell culture.

Ozturk SS.

Adv Biochem Eng Biotechnol. 2014;139:69-92. doi: 10.1007/10_2013_259.

PMID:
24429549
6.

A quality by design study applied to an industrial pharmaceutical fluid bed granulation.

Lourenço V, Lochmann D, Reich G, Menezes JC, Herdling T, Schewitz J.

Eur J Pharm Biopharm. 2012 Jun;81(2):438-47. doi: 10.1016/j.ejpb.2012.03.003. Epub 2012 Mar 13.

PMID:
22446063
7.

Integrated Application of Quality-by-Design Principles to Drug Product Development: A Case Study of Brivanib Alaninate Film-Coated Tablets.

Badawy SI, Narang AS, LaMarche KR, Subramanian GA, Varia SA, Lin J, Stevens T, Shah PA.

J Pharm Sci. 2016 Jan;105(1):168-81. doi: 10.1016/j.xphs.2015.11.023. Epub 2016 Jan 13.

PMID:
26852852
8.

Quality by design and process analytical technology for sterile products--where are we now?

Riley BS, Li X.

AAPS PharmSciTech. 2011 Mar;12(1):114-8. doi: 10.1208/s12249-010-9566-x. Epub 2010 Dec 23. Review.

9.

Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes.

Yan B, Li Y, Guo Z, Qu H.

Phytochem Anal. 2014 Jan-Feb;25(1):59-65. doi: 10.1002/pca.2463. Epub 2013 Sep 23.

PMID:
24108478
10.

Application of Quality by Design to the characterization of the cell culture process of an Fc-Fusion protein.

Rouiller Y, Solacroup T, Deparis V, Barbafieri M, Gleixner R, Broly H, Eon-Duval A.

Eur J Pharm Biopharm. 2012 Jun;81(2):426-37. doi: 10.1016/j.ejpb.2012.02.018. Epub 2012 Mar 9.

PMID:
22426134
11.

Implementation of QbD for the development of a vaccine candidate.

Haas J, Franklin A, Houser M, Maraldo D, Mikola M, Ortiz R, Sullivan E, Otero JM.

Vaccine. 2014 May 19;32(24):2927-30. doi: 10.1016/j.vaccine.2014.02.028. Epub 2014 Mar 2.

PMID:
24598725
12.

Information Processing: Rate-Based Investigation of Cell Physiological Changes along Design Space Development.

Sagmeister P, Wechselberger P, Herwig C.

PDA J Pharm Sci Technol. 2012 Nov-Dec;66(6):526-41. doi: 10.5731/pdajpst.2012.00889.

PMID:
23183649
13.

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: application of quality by design (QbD) principles.

Jiang C, Flansburg L, Ghose S, Jorjorian P, Shukla AA.

Biotechnol Bioeng. 2010 Dec 15;107(6):985-97. doi: 10.1002/bit.22894.

PMID:
20683852
14.

Pharmaceutical quality by design: product and process development, understanding, and control.

Yu LX.

Pharm Res. 2008 Apr;25(4):781-91. doi: 10.1007/s11095-007-9511-1. Epub 2008 Jan 10. Erratum in: Pharm Res. 2008 Oct;25(10):2463.

PMID:
18185986
15.

Quality-by-Design approach to monitor the operation of a batch bioreactor in an industrial avian vaccine manufacturing process.

Largoni M, Facco P, Bernini D, Bezzo F, Barolo M.

J Biotechnol. 2015 Oct 10;211:87-96. doi: 10.1016/j.jbiotec.2015.07.001. Epub 2015 Jul 26.

PMID:
26216182
16.

Quality by design: concepts for ANDAs.

Lionberger RA, Lee SL, Lee L, Raw A, Yu LX.

AAPS J. 2008 Jun;10(2):268-76. doi: 10.1208/s12248-008-9026-7. Epub 2008 May 9.

17.

Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT).

Aksu B, De Beer T, Folestad S, Ketolainen J, Lindén H, Lopes JA, de Matas M, Oostra W, Rantanen J, Weimer M.

Eur J Pharm Sci. 2012 Sep 29;47(2):402-5. doi: 10.1016/j.ejps.2012.06.009. Epub 2012 Jun 26.

PMID:
22749874
18.

Roadmap for implementation of quality by design (QbD) for biotechnology products.

Rathore AS.

Trends Biotechnol. 2009 Sep;27(9):546-53. doi: 10.1016/j.tibtech.2009.06.006. Epub 2009 Aug 3. Review.

PMID:
19647883
19.

Conversion of a CHO cell culture process from perfusion to fed-batch technology without altering product quality.

Meuwly F, Weber U, Ziegler T, Gervais A, Mastrangeli R, Crisci C, Rossi M, Bernard A, von Stockar U, Kadouri A.

J Biotechnol. 2006 May 3;123(1):106-16. Epub 2005 Dec 1.

PMID:
16324762
20.

Process analytical technology (PAT) for biopharmaceutical products: Part II. Concepts and applications.

Read EK, Shah RB, Riley BS, Park JT, Brorson KA, Rathore AS.

Biotechnol Bioeng. 2010 Feb 1;105(2):285-95. doi: 10.1002/bit.22529.

PMID:
19731253
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