SYMPOSIUM - Emerging Biophysical Techniques in Biologics Formulation and Process Development
Conference: AAPS National Biotechnology Conference
Where: Hilton San Francisco - Union Square
Symposium: Emerging BioPhysical Techniques in Biologics Formulation and Process Development
When: Wednesday May 19, 2010 - 1:30-4:00pm
Details: AAPS National Biotechnology Conference
Dr. John F. Carpenter (Co-Director - Center for Pharmaceutical Biotechnology, University of Colorado Denver) is scheduled to present "Roles of Subvisible Particles in Aggregation Pathways for Therapeutic Proteins."
Symposium Description: This session highlights recent advances and application of emerging technologies in parenteral (injectable) dosage form development and characterization of biologics. Novel applications include superior understanding of degradation mechanism drug substance, characterization of 'new species", Impact of process on stability such as surface adsorption and foaming, and deciphering nucleating species of aggregation. Emerging technologies Include spectroscopic methods, sizing techniques for aggregates and particulates matters, surface interaction measurements, and physical stability methods.
New Journal Article from Centocor re. MFI
AUTHORS
John F. Carpenter, Theodore W. Randolph, Wim Jiskoot, Daan J.A. Crommelin, C. Russell Middaugh, Gerhard Winter, Ying-Xin Fan, Susan Kirshner, Daniela Verthelyi, Steven Kozlowski, Kathleen A. Clouse, Patrick G. Swann, Amy Rosenberg, Barry Cherney (2009). Journal of Pharmaceutical Sciences, 98(4): 1201-1205
Published online in Wiley InterScience. DOI 10.1002/jps.21530
The complete article can be found at:
http://www3.interscience.wiley.com/journal/121378778/abstract
Scientific Publication - EXPERT REVIEW, Stability of Protein Pharmaceuticals: An Update
AUTHORS
Mark Cornell Manning, Danny K. Chou, Brian M. Murphy, Robert W. Payne and Derrick S. Katayama (2010). Pharmaceutical Research, 27(4) April 2010: 544-575
Published online in Springer Netherlands. DOI 10.1007/s11095-009-0045-6
REFERENCE TO MFI...
Page 555
"...More recently, subvisible particulates have received a great deal of attention, both from regulatory agencies as well as researchers in the field (322). There is concern that these might be the most immunogenic of particulates found in protein products (301). Furthermore, new analytical methods, such as micro-flow imaging (MFI) allow one to not only quantify particles across this size range (323,324) but also capture images of the individual particles, making it possible to distinguish protein aggregates from foreign materials (325)...."
The complete article can be found at:
http://www.springerlink.com/content/c3h6554t3162upv1/
Authors References:
301. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8:E501-7.
322. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJA, Middaugh CR, Winter G, et al. Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci. 2009;98:1201-5.
323. Sharma DK, King D, Moore P, Oma P, Thomas D. Flow microscopy for particlulate analysis in parenteral and pharmaceutical fluids. Eur J Parenteral Pharm Sci. 2007;12:97-101.
324. Huang C-T, Sharma D, Oma P, Krishnamurthy R. Quantitation of protein particles in parenteral solutions using micro-flow imaging. J Pharm Sci. 2009;98:3058-71.
325. Sharma DK, Oma P, Krishnan S. Silicone microdroplets in protein formulations. Pharm Technol. 2009;33(4):74-9.
