Conclusion

In light of the numerous challenges in biologics processing, such as the wide variety of molecules and applications, increased quality and regulatory requirements, and cost pressure on drug financing, the development of new downstream processing technologies is essential.

Applying PAT systems, such as ILD systems and at line monitoring, can significantly increase process control and aid cost reduction. Further development of chromatographic media or membranes through the use of specific ligand technologies and optimal media design, with single-use materials, are additional solutions that also can improve quality and productivity. These improvements can be coupled with new process design, such as semicontinuous or continuous processing, which can greatly enhance process intensification while simultaneously reducing costs.

The author wishes to thank Henri Colin, PhD, Consultant at Ulysse Consult, Laurent David, Senior Scientific Expert at Novasep Process, and Velvet Mitchem-Thery, Event and Web Coordinator at Groupe Novasep.

Margit Holzer, PhD, is R&D and technology director at Novasep Process Process Eiffel, BP 50 Blvd de la Moselle, Pompey, France, 54340, tel. + 33 383 497021, fax +33 383 497003, margit.holzer@novasep.com
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References

1. FDA, Guidance for Industry, PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance (Rockville, MD, September 2004).

2. M. Holzer, "Impact and Benefits of PAT in Industrial Downstream Processing" at the BioProcess International Conference (Raleigh, NC, October 2009).

3. L. David, "Evaluation of the Process Performance and Economical Impact of Sequential Multi-Column Chromatography in Downstream Processing" presentation given at IBC Biopharmaceutical Development & Production Week (Bellevue, WA, March 2011).

4. A.Sinclair, "Continuous Downstream Processing: The Improvement of Tomorrow for Biological Production - Economic Analysis" presentation given at BioProcess International Conference (Düsseldorf, Germany, April 2009).