Advances in Non-Protein A Purification Processes for Human Monoclonal Antibodies - In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a

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Advances in Non-Protein A Purification Processes for Human Monoclonal Antibodies
In three non-affinity purification processes based on cation exchange capture with high binding capacity, applying a host cell protein exclusion strategy enabled robust scale up and better economics.


BioPharm International Supplements


Conclusions

A scalable and robust non-affinity process scheme with two ion exchange process steps provides a further opportunity to reduce the manufacturing costs for recombinant antibodies and thus the cost of goods. The two processing steps can be combined into an entirely membrane-based process scheme. The successful operation of contiguous anion and cation exchange membranes was recently reported for a commercial antibody manufacturing process.14 Even in the case of the slightly lower binding capacity of CEX membranes, the high flow rates can still offer further economic and operational advantages.

ALAHARI ARUNAKUMARI, PhD, is senior director of process development, JUE (MICHELLE) WANG, PhD, is assistant director, purification process development, and GISELA FERREIRA, PhD, is a senior process engineer, purification process development, all at Medarex Inc, Bloomsbury, NJ, 908.479.2451,

References

1. Glynn J. Process-scale precipitation of impurities in mammalian cell culture broth. BioPharm Int. 2008 Mar (supplement):12–18.

2. Glynn J. Development of a precipitation alternative and improvements for Protein A for impurity reduction in clarified broth containing a monoclonal antibody. BioProcess International Conference; 2008 Sept. 23–26; Anaheim, CA.

3. Wang J, Diehl T, Watkins-Fischl M, Perkins D, Aguiar D, Arunakumari, A. Optimizing the primary recovery step in non-affinity purification schemes for HuMabs. BioPharm Int. 2008 Mar (supplement): 4–10.

4. Noel R, Lihme A, Lim J, Mol O, Sinclair A. Disposable adsorption systems for monoclonal antibody processing: practical, scalable operations for multi-product facilities. Recovery of Biological Products, 2008 June 22–27; Quebec City, Canada.

5. Ramanan S, Stenson R. Method of isolating antibodies by precipitation. International patent WO/2008/100578. A2. 2008 Aug 21.

6. Arunakumari A. Extending the efficiency of cation exchange bioseparations by novel approach for high capacity Humabs manufacturing. Recovery of Biological Products; 2008 June 22–27; Quebec City, Canada.

7. Arunakumari A, Wang J. Purification of human monoclonal antibodies: non-Protein A strategies. In: Gottschalk U, editor. Process Scale Purification of Antibodies. Hoboken, NJ: John Wiley & Sons, Inc.; 2009; p. 103–123.

8. Arunakumari A, Wang J, Ferreira G. Alternatives to Protein A: Improved downstream process design for human monoclonal antibody production. Biopharm Int. 2007 Feb (supplement): 36–40.

9. Ingham KC. Precipitation of proteins with polyethylene glycol. Methods Enzymol. 1990;182:301–6.

10. Gottschalk U. (2006) The renaissance of protein purification. BioPharm Int. 2006 June (supplement): 8–9.

11. Low D, O'Leary R, Pujar NS. Future of antibody purification. J Chromatogr B. 2007;848:48–63.

12. Percivia press release: DSM and Crucell announce record achievement in PER.C6 Technology. Heerlen/Leiden, the Netherlands; 2008 June 16.

13. Seng RL, Lundblad JL. Viral inactivation process. United States patent US 4939176. 1990 Dec 20.

14. Giovannoni L, Ventani M, Gottschalk U. Antibody purification using membrane adsorbers. BioPharm Int. 2008 Dec;21(12):48–52.


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