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« BIOPHARMACEUTICALS
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References
1.
2.
3.
4.
5.
6.
7.
8.
9.
16.
Kelly, B. 92009) Industrialization of mAb production technology. The bioprocess industry at
a crossroad. mAbs, I, 443-452.
Shukla, A.A. and Thömmes, J. (2012) Recent advances in Large-Molecule production of
monoclonal antibodies and related proteins, Trends Biotechnol., 28 (5), 253-261.
Ozturk, S.S. and Hu, W.S. (eds) (2006) Cell culture technology for pharmaceutical and CellBased
Therapies, CRC Press, Taylor & Francis Group, Boca Raton, FL.
Guideline on Real Time Release Testing (formerly Guideline on Parametric Release). Real
Time Release Testing guideline (europa.eu)
Q13 Continuous Manufacturing of Drug Substances and Drug Products, March 2023; Q13
Continuous Manufacturing of Drug Substances and Drug Products (fda.gov)
ICH Harmonised Guideline, Q14 Analytical Procedure Development, Step 2, 08/26/2022;
Q14 Analytical Procedure Development (fda.gov)
ICH Harmonized Guideline, Validation of Analytical Procedures Q2(R2), March, 24 2022;
ICH_Q2-R2_Document_Step2_Guideline_2022_0324.pdf
ICH Harmonized Tripartite Guideline Pharmaceutical Development Q8(R2), August 2009;
Q8(R2) Guideline.pdf (ich.org)
Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development,
Manufacturing, and Quality Assurance, September 2004; Guidance for Industry PAT - A
Framework for Innovative Pharmaceutical Development, manufacturing, and Quality
Assurance (fda.gov)
10.
Bonham-Carter, J. and Shevitz, J. 920110 A brief history of perfusion biomanufacturing
how high. Concentration cultures will characterize the factory of the future. BioProcess Int.,
9(9), 24-31.
11. Ozturk, S.S. (2013) Cell culture technology; a historical perspective with future directions.
Keynote lecture. annual biomanufacturing Leaders Summit, Boston, MA, pp. 11-12.
12. Warikoo, V., Godawat, R., Brower, K., Jain, S., Cummings, D., Simons, E., Johnson, T., Walther,
J., Yu, M., Wright, B., McLarty, K.P. Hwang, C., Zhou, W., Riske, F., and Konstantinov, K.,
(2012) Integrated Continuous Production of recombinant therapeutic proteins. Biotechnol.
Bioeng., 109 (12), 3018-3029.
13.
14.
Vogel, J.H., Nguyen, H., Giovannini, R., Ignowski, J., Garger, S., Salgotra, A., and Tom, J.
(2012) A new large-scale manufacturing platform for complex biopharmaceuticals.
Biotechnol. Bioeng., 109 (12), 3049-3058.
Pollack, J., Ho, S. V., and Farid, S.S. (2013) Fed-Batch and Perfusion culture Processes:
economic, environmental, and operational feasibility under uncertainty. Biotechnol.
Bioeng., 110 (1), 206-219.
Jayapal, K.P., Wlaschin, K.F., Hu, W.-S., and Yep, M.G.S. (2007) Recombinant protein
therapeutics from CHO cells-20 years and counting. Chem. Eng. Prog., 103, 40-47.
Li, F., Vijayasankaran, N., Shen, a., Kiss, R., and Amannullah, A. (2010) Cell culture processes
for monoclonal antibody production, mAbs, 2 (5), 466-477.
17. Andersen, D.C. and Reilly, D.E. (2004) Production technologies for monoclonal antibodies
and their fragments. Curr. Open. Biotechnol., 15, 456-462.
18. Ozturk, S.S. and Kompala, D., (2006) Optimization of high cell density perfusion columns,
in Cell Culture Technology for Pharmaceutical and Cell-Based Therapies (eds S.S. Ozturk and
W.-S. Hu), Boca Raton, FL. Pp. 387-416.
19. Developments and opportunities in continuous biopharmaceutical manufacturing,
Ohnmar Khanal & Abraham M. Lenhoff, Article: 1903664, Received 04 Dec 2020, accepted
11 Mar 2021, Published online: 11 Apr 2021. Full article: Developments and opportunities
in continuous biopharmaceutical manufacturing (tandfonline.com)
20.
11th Annual Report and Survey of Biopharmaceutical Manufacturing, E. Langer, BioPlan
Associates, April 2014, pp. 103-116.
21. Ozturk, S.S. (2013) Cell culture technology: a historical perspective with future directions.
Keynote lecture, Annual Biomanufacturing Leaders Summit.
22. Dream, Robert, Continuous Manufacturing Progress and the Bio/Pharmaceutical Industry
" Reality or Fad " , American Pharmaceutical Review, Tuesday, August 15, 2017.
23. Hummel J, Pagkaliwangan M, Gjoka X, Davidovits T, Stock R, Ransohoff T, Gantier R,
Schofield M, Modeling the downstream processing of monoclonal antibodies reveals cost
advantages for continuous methods for a broad range of manufacturing scales. Biotechnol
J. 2019; 14(2): 17000665. Doi:10.1002/biot.201.201700665.
24.
FDA, Drug shortage: root cause and potential solutions [internet]. 2019 [cited 2020 Apr
7]:1-24. Available from: https://www.fda.gov/news-events/press-announcement/
statement-fda-new-report-regarding-root-caus-and-potential-solutions-drug-shortages
25.
Fisher AC, Kamga MH, Agarabi C, Bronson K, Lee SL, Yoon S. the current scientific
and regulatory landscape in advancing integrated continuous biopharmaceutical
manufacturing, Trends Biotechnol. 2019;37(3):253-67. Doi: 10.1016/j.tibtech.2018.08.008.
26.
Srai JS, Badman C, Krumme M, Futran M, Johnson C, Future supply chains enabled by
continuous processing-opportunities and challenges. Many 20-21, 2014, continuous
manufacturing symposium. J. Pharm Sci. 2015;104(3):840-49. Dot:10.1002/jps.24343.
27.
Konstantin Konstantinov, VP, Late-Stage Process Development, Bio-Realization, Sanofi,
(noted figures, via e-mal). 12/2016.
www.americanpharmaceuticalreview.com |
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http://www.europa.eu http://www.fda.gov http://www.tandfonline.com http://www.fda.gov http://www.ich.org http://www.fda.gov https://www.fda.gov/news-events/press-announcement/statement-fda-new-report-regarding-root-caus-and-potential-solutions-drug-shortages http://www.americanpharmaceuticalreview.com

APR May/June 2023

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