Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product - Pharmaceutical Technology

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Integration of Large-Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product
The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.


Pharmaceutical Technology
Volume 33, Issue 1, pp. 62-70

References

1. K. DiBlasi et al., "Disposable Biopharmaceutical Processes, Myth or Reality?," BioPharm Int., Nov. 2006 supplement, 6–16.

2. R. Francis, "Efficient Process Development Strategies Can Translate into Robust Large-Scale Manufacturing," presented at the IBC Conference, San Francisco, Nov. 2006.

3. C. Jones and A. Denton, "Integration of Large Scale Chromatography with Nanofiltration for an Ovine Polyclonal Product," presented at the European Downstream Technology Forum, Sartorius College, Goettingen, Germany, May 2007.

4. K. Tarrach et al., "The Effect of Flux Decay on a 20-nm Nanofilter for Virus Retention," BioPharm Int., April, 58–63, 2007.

5. K. Tarrach, "Integrative Strategies for Viral Clearance," presented at the 4th Annual Biological Production Forum, Edinburgh, Apr. 2005.

6. K. Brorson, "Virus Filter Validation and Performance," presented at the Recovery of Biological Products XII conference, Phoenix, AZ, Apr. 2006.

7. EMEA/CPMP, Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses (London, Feb. 1996), available at http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf. accessed on Dec. 19, 2008.

8. ICH and FDA, Q5A Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (Geneva, Switzerland and Rockville, MD, Sept. 1998).

9. M. Cabatingan, "Impact of Virus Stock Quality on Virus Filter Validation, A Case Study," BioProcess Int., Nov. 2005 supplement, 39–43.

10. T. Ireland et al., "Viral Filtration of Plasma-Derived Human IgG: A Case Study Using Viresolve NFP," BioPharm Int. 17 (11), 38–44 (2004).

11. A. Higuchi et al., "Effect of Aggregated Protein Sizes on the Flux of Protein Solution Through Microporous Membranes." J. Membrane Sci. 236 (1–2), 137–144 (2004).

12. K. Tarrach, "Virus Filter Positioning in the Purification Process of Cell Culture Intermediates and Flow Decay Aspects Associated with Small Non-Enveloped Virus Retention," presented at the BioProcess International European Conference and Exhibition, Paris, Apr. 2007.


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