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Items: 1 to 20 of 58

1.

A review on current downstream bio-processing technology of vaccine products.

Li M, Qiu YX.

Vaccine. 2013 Feb 18;31(9):1264-7. doi: 10.1016/j.vaccine.2012.12.056. Epub 2013 Jan 9. Review.

PMID:
23313813
2.

Vaccine process technology.

Josefsberg JO, Buckland B.

Biotechnol Bioeng. 2012 Jun;109(6):1443-60. doi: 10.1002/bit.24493. Epub 2012 Mar 30. Review.

PMID:
22407777
3.

Process analytical technology (PAT) for biopharmaceutical products.

Rathore AS, Bhambure R, Ghare V.

Anal Bioanal Chem. 2010 Sep;398(1):137-54. doi: 10.1007/s00216-010-3781-x. Epub 2010 May 18. Review.

PMID:
20480150
4.

Single-use disposable technologies for biopharmaceutical manufacturing.

Shukla AA, Gottschalk U.

Trends Biotechnol. 2013 Mar;31(3):147-54. doi: 10.1016/j.tibtech.2012.10.004. Epub 2012 Nov 21. Review.

PMID:
23178074
5.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

Sahoo N, Choudhury K, Manchikanti P.

BioDrugs. 2009;23(4):217-29. doi: 10.2165/11317110-000000000-00000. Review.

PMID:
19697964
6.

Latent variable modeling to assist the implementation of Quality-by-Design paradigms in pharmaceutical development and manufacturing: a review.

Tomba E, Facco P, Bezzo F, Barolo M.

Int J Pharm. 2013 Nov 30;457(1):283-97. doi: 10.1016/j.ijpharm.2013.08.074. Epub 2013 Sep 7. Review.

PMID:
24016743
7.

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.

8.

Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations.

Mercier SM, Diepenbroek B, Wijffels RH, Streefland M.

Trends Biotechnol. 2014 Jun;32(6):329-36. doi: 10.1016/j.tibtech.2014.03.008. Epub 2014 Apr 12. Review.

PMID:
24732022
9.

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
10.

Improved virus purification processes for vaccines and gene therapy.

Nestola P, Peixoto C, Silva RR, Alves PM, Mota JP, Carrondo MJ.

Biotechnol Bioeng. 2015 May;112(5):843-57. doi: 10.1002/bit.25545. Epub 2015 Mar 10. Review.

PMID:
25677990
11.

Process analytical technologies (PAT) in freeze-drying of parenteral products.

Patel SM, Pikal M.

Pharm Dev Technol. 2009;14(6):567-87. doi: 10.3109/10837450903295116. Review.

PMID:
19883247
12.

Applications of process analytical technology to crystallization processes.

Yu LX, Lionberger RA, Raw AS, D'Costa R, Wu H, Hussain AS.

Adv Drug Deliv Rev. 2004 Feb 23;56(3):349-69. Review.

PMID:
14962586
13.
14.

Process analytical technology in the pharmaceutical industry: a toolkit for continuous improvement.

Scott B, Wilcock A.

PDA J Pharm Sci Technol. 2006 Jan-Feb;60(1):17-53. Review.

PMID:
17089677
15.

Continuous downstream processing of biopharmaceuticals.

Jungbauer A.

Trends Biotechnol. 2013 Aug;31(8):479-92. doi: 10.1016/j.tibtech.2013.05.011. Epub 2013 Jul 10. Review.

PMID:
23849674
16.

Chemometrics-based process analytical technology (PAT) tools: applications and adaptation in pharmaceutical and biopharmaceutical industries.

Challa S, Potumarthi R.

Appl Biochem Biotechnol. 2013 Jan;169(1):66-76. doi: 10.1007/s12010-012-9950-y. Epub 2012 Nov 10. Review.

PMID:
23138336
17.

Stability studies needed to define the handling and transport conditions of sensitive pharmaceutical or biotechnological products.

Ammann C.

AAPS PharmSciTech. 2011 Dec;12(4):1264-75. doi: 10.1208/s12249-011-9684-0. Epub 2011 Sep 27. Review.

18.

Aggregates in monoclonal antibody manufacturing processes.

Vázquez-Rey M, Lang DA.

Biotechnol Bioeng. 2011 Jul;108(7):1494-508. doi: 10.1002/bit.23155. Epub 2011 Apr 20. Review.

PMID:
21480193
19.

Quality control and analytical methods for baculovirus-based products.

Roldão A, Vicente T, Peixoto C, Carrondo MJ, Alves PM.

J Invertebr Pathol. 2011 Jul;107 Suppl:S94-105. doi: 10.1016/j.jip.2011.05.009. Review.

PMID:
21784235
20.

Continuous processing and the applications of online tools in pharmaceutical product manufacture: developments and examples.

Ooi SM, Sarkar S, van Varenbergh G, Schoeters K, Heng PW.

Ther Deliv. 2013 Apr;4(4):463-70. doi: 10.4155/tde.13.11. Review.

PMID:
23557287
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