Technologies for Downstream Processing in Biologics - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Technologies for Downstream Processing in Biologics
The author describes recent developments to help overcome the downstream processing bottleneck. This article is part of a special issue on Sterile Manufacturing and Bioprocessing.


Pharmaceutical Technology
Volume 35, pp. s30-s34

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.

Acknowledgments

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,
.

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology,
Click here