Continuous manufacturing: A changing processing paradigm

BioPharm International

Volumn 28, Issue 4, 2015, Pages 20-41

  Hernandez, Randi ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

MONOCLONAL ANTIBODY;

ARTICLE; BIOTECHNOLOGY; CHROMATOGRAPHY; COST; DRUG APPROVAL; DRUG MANUFACTURE; DRUG QUALITY; DRUG SCREENING; FOOD AND DRUG ADMINISTRATION; QUALITY CONTROL;

EID: 84937900704     PISSN: 1542166X     EISSN: 19391862     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (16)

1. BioPlan Associates, “Continuous Bioprocessing and Perfusion: Increased Adoption Expected,” in 11th Annual Report and Survey of Biopharmaceutical Manufacturing, E. Langer, Ed. (April 2014), pp. 103–116
2. S. Ghose, R. Nordberg, and A. Forss, “The Future of Continuous Downstream Processing,” on-demand webcast on BioPharm International, https://event.on24.com/eventRegistration/EventLobbyServlet?target=registration.jsp&eventid=890993&sessionid=1&key=63C475F147ABC8B55EFC1F0A20D92723&sourcep age=register, accessed Feb. 20, 2015
3. K.B. Konstantinov and C.L. Cooney, “White Paper on Continuous Bioprocessing,” presentation at the International Symposium on Continuous Manufacturing of Pharmaceuticals: Implementation, Technology & Regulatory (Cambridge, MA, 2014).
4. S. Chatterjee, “FDA Perspective on Continuous Manufacturing,” presentation at the IFPAC Annual Meeting (Baltimore, MD, 2012).
5. G. Allison et al., “Regulatory and Quality Considerations for Continuous Manufacturing,” presentation at the International Symposium on Continuous Manufacturing of Pharmaceuticals: Implementation, Technology & Regulatory (Cambridge, MA, 2014).
6. P. Thomas, “With Continuous Operations, Can Drug Manufacturing Become a Rock Star?,” http://www.pharmaqbd.com/novartis-mit_evans_continuous_manufacturing/, accessed on February 23, 2015
7. C. Challener, “Bioprocessing & Sterile Manufacturing,” supplement to Pharm. Technol. 38 (2014).
8. M. Bisschops et al., “Single-Use, Continuous-Countercurrent, Multicolumn Chromatography,” supplement to BioProcess Internat. (2009), http://www.bioprocessintl.com/downstreamprocessing/chromatography/single-use-continuous-countercurrentmulticolumn-chromatography-184186/, accessed Feb. 15, 2015
9. J.D. Rockoff, “Drug Making Breaks Away From Its Old Ways,” The Wall Street Journal, Feb. 8, 2015, http://www.wsj.com/articles/drug-making-breaks-awayfrom-its-old-ways-1423444049, accessed Feb. 22, 2015
10. Hemispherx Biopharma, “Hemispherx Biopharma Announces the Completion of the Newly Upgraded Alferon Facility: Commercial Production of Alferon is in the Final Stage Integrating Continuous Flow Manufacturing Technology,” Press Release, March 2, 2015
11. Amgen, “Amgen Outlines Strategy, Growth Objectives And Capital Allocation Plans,” Press Release, Oct. 28, 2014
12. Vertex, Form 10-K Annual Report, Filed Feb 11, 2014, http://investors.vrtx.com/secfiling.cfm?filingID=875320-14-15& CIK=875320, accessed March 1, 2015
13. Genzyme, Integrated Continuous Manufacturing of Therapeutic Protein Drug Substances, US patent 20140255994 A1, March 3, 2014
14. R. Patil, “Integrated Fully Continuous Production of Recombinant Therapeutic Proteins,” presentation at the Biomanufacturing and Process Development’s Continuous Bioprocess Symposium (Durham, NC, 2014).
15. T. Wallack, “Novartis to give MIT $65m to find new way to produce drugs,” The Boston Globe, Sept. 28, 2007, http://www.boston.com/business/articles/2007/09/28/novartis_to_give_mit_65m_to_find_new_way_to_produce:drugs/?page=full, accessed March 1, 2015
16. M. Peplow, “Organic synthesis: The robo-chemist,” Nature 512, pp. 20–22 (August 07, 2014), doi:10.1038/512020a.