Research ArticleResearch
Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality
Benson Gikanga, Yufei Chen, Oliver B. Stauch and Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology March 2015, 69 (2) 284-296; DOI: https://doi.org/10.5731/pdajpst.2015.01031
Benson Gikanga
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
Yufei Chen
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
Oliver B. Stauch
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
Yuh-Fun Maa
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

References
- 1.↵
- Eibl R.,
- Eibl D.
- Werner S.,
- Kraume M.,
- Eibl D.
- 2.↵
- Eibl R.,
- Eibl D.
- Eibl D.,
- Peuker T.,
- Eibl R.
- 3.↵
- Cromwell M. E.,
- Hilario E.,
- Jacobson F.
- 4.↵
- 5.↵
- 6.↵
- 7.↵
- 8.↵
- Sinclair A.,
- Monge M.
- 9.↵
Sartorius Stedim Biotech website, Standard Flexel® for LevMixer® 50 L to 1,000 L, http://www.sartorius.com/fileadmin/fm-dam/sartorius_media/Bioprocess-Solutions/Fluid_Management/Single-Use_Mixing/Data_Sheets/Data_Flexel3D_LevMix_System_for_Palletank_SPT2012-e.pdf (accessed April 20, 2014).
- 10.↵
Sartorius Stedim Biotech website, Standard Flexel® for Magnetic Mixer 50 L to 2,000 L, http://microsite.sartorius.com/fileadmin/sartorius_pdf/alle/biotech/Data_Flexel_for_Magnatic_Mixer_50L-2000L_SPT2023-e.pdf (accessed April 20, 2014).
- 11.↵
Millipore website, Mobius® Disposable Mixing System User Guide, http://www.millipore.com/userguides.nsf/a73664f9f981af8c852569b9005b4eee/02505c45cc505b0d852575c90062ff4d/$FILE/00101867pu.pdf (accessed April 20, 2014).
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 2
March/April 2015
Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality
Benson Gikanga, Yufei Chen, Oliver B. Stauch, Yuh-Fun Maa
PDA Journal of Pharmaceutical Science and Technology Mar 2015, 69 (2) 284-296; DOI: 10.5731/pdajpst.2015.01031
Jump to section
Related Articles
- No related articles found.