Managing unexpected events in the manufacturing of biologic medicines

BioDrugs

Volumn 27, Issue 4, 2013, Pages 305-316

  Grampp, Gustavo ^a   Ramanan, Sundar ^a  

^a AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT;

AERATION; BIOTECHNOLOGY; CELL CULTURE; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; PRIORITY JOURNAL; REVIEW;

EID: 84880782388     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.1007/s40259-013-0018-5     Document Type: Review

References (31)

1. Gatesman ML, Smith TJ. The shortage of essential chemotherapy drugs in the United States. N Engl J Med. 2011;365(18):1653-5.
2. Kaakeh R, Sweet BV, Reilly C, Bush C, DeLoach S, Higgins B, et al. Impact of drug shortages on U.S. health systems. Am J Health Syst Pharm. 2011;68(19):1811-9.
3. Ventola CL. The drug shortage crisis in the United States: causes, impact, and management strategies. P T. 2011;36(11):740-57.
4. US Food and Drug Administration. Current drug shortages. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm. Accessed 13 Nov 2012.
5. Woodcock J, Wosinska M. Economic and technological drivers of generic sterile injectable drug shortages. Clin Pharmacol Ther. 2013;93(2):170-6.
6. Weick KE, Sutcliffe KM. Managing the unexpected: resilient performance in an age of uncertainty. 2nd ed. San Francisco: Wiley; 2007.
7. Sasaki H, Bothner B, Dell A, Fukuda M. Carbohydrate structure of erythropoietin expressed in Chinese hamster ovary cells by a human erythropoietin cDNA. J Biol Chem. 1987;262(25):12059-76.
8. Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001;84(Suppl 1):3-10.
9. Hokke CH, Bergwerff AA, van Dedem GW, van Oostrum J, Kamerling JP, Vliegenthart JF. Sialylated carbohydrate chains of recombinant human glycoproteins expressed in Chinese hamster ovary cells contain traces of N-glycolylneuraminic acid. FEBS Lett. 1990;275(1-2):9-14.
10. Ghaderi D, Taylor RE, Padler-Karavani V, Diaz S, Varki A. Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins. Nat Biotechnol. 2010;28(8):863-7.
11. Prigge ST, Kolhekar AS, Eipper BA, Mains RE, Amzel LM. Amidation of bioactive peptides: the structure of peptidylglycine alpha-hydroxylating monooxygenase. Science. 1997;278(5341):1300-5.
12. Boven K, Stryker S, Knight J, Thomas A, van Regenmortel M, Kemeny DM, et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int. 2005;67(6):2346-53.
13. Haag-Weber M, Eckardt KU, Horl WH, Roger SD, Vetter A, Roth K. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-alpha (HX575) in non-dialysis patients with renal anemia: a multi-center, randomized, double-blind study. Clin Nephrol. 2012;77(1):8-17.
14. Seidl A, Hainzl O, Richter M, Fischer R, Bohm S, Deutel B, et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity. Pharm Res. 2012;29(6):1454-67.
15. Joubert MK, Hokom M, Eakin C, Zhou L, Deshpande M, Baker MP, et al. Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses. J Biol Chem. 2012;287(30):25266-79.
16. Sauerborn M, Brinks V, Jiskoot W, Schellekens H. Immunological mechanism underlying the immune response to recombinant human protein therapeutics. Trends Pharmacol Sci. 2010;31(2):53-9.
17. Jiang Y, Nashed-Samuel Y, Li C, Liu W, Pollastrini J, Mallard D, et al. Tungsten-induced protein aggregation: solution behavior. J Pharm Sci. 2009;98(12):4695-710.
18. Zhang B, Towers EW, Poppe L, Cockrill SL. Analytical characterization of a novel degradation product in a PEGylated recombinant protein. J Pharm Sci. 2011;100(11):4607-16.
19. Vinther A. A novel bacterial contamination in cell culture manufacturing Leptospira licerasiae. PDA WCC Meeting July 19, 2012. http://www.wccpda.org/ Pages/Archives/Anders%20Vinther%20Leptospira%20PDA%20WCC%2019%20Jul%202012.ppt. Accessed 30 Nov 2012.
20. US Food and Drug Administration. Quality systems. http://www.fda.gov/ Drugs/DevelopmentApprovalProcess/Manufacturing/ucm278584.htm. Accessed 13 Nov 2012.
21. US Food and Drug Administration. FDA Form 483 frequently asked questions. http://www.fda.gov/ICECI/EnforcementActions/ucm256377.htm. Accessed 30 Nov 2012.
22. Pritchett T. A 483 primer: learning from the mistakes of others. Bioprocess Int. 2011;9:12-6.
23. US Food and Drug Administration. Regulatory procedures manual, Chapter 4: advisory actions. http://www.fda.gov/downloads/ICECI/ComplianceManuals/ RegulatoryProceduresManual/UCM074330.pdf. Accessed 20 Feb 2013.
24. US Food and Drug Administration. About Warning and Close-Out Letters. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm278624.htm. Accessed 30 Nov 2012.
25. US Food and Drug Administration. Inspections, compliance, enforcement, and criminal investigations. http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/default.htm. Accessed 30 Nov 2012.
26. US Food and Drug Administration. News & events. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ucm289224.htm. Accessed 30 Nov 2012.
27. US Food and Drug Administration. Regulatory procedures manual, Chapter 5: administrative actions. http://www.fda.gov/downloads/ICECI/ComplianceManuals/ RegulatoryProceduresManual/UCM074324.pdf. Accessed 20 Feb 2013.
28. Genazzani AA, Biggio G, Caputi AP, Del Tacca M, Drago F, Fantozzi R, et al. Biosimilar drugs: concerns and opportunities. Biodrugs. 2007;21(6):351-6.
29. Prugnaud JL. Similarity of biotechnology-derived medicinal products: specific problems and new regulatory framework. Br J Clin Pharmacol. 2008;65(4):619-20.
30. Roger SD. Biosimilars: how similar or dissimilar are they? Nephrology (Carlton). 2006;11(4):341-6.
31. Gottlieb S. Biosimilars: policy, clinical, and regulatory considerations. Am J Health Syst Pharm. 2008;65(14 Suppl 6):S2-8.