Skip to main content

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
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
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yufei Chen
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Oliver B. Stauch
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yuh-Fun Maa
Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: maay@gene.com
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Eibl R.,
    2. Eibl D.
    1. Werner S.,
    2. Kraume M.,
    3. Eibl D.
    Bag Mixing Systems for Single-Use. In Single-Use Technology in Biopharmaceutical Manufacture, Eibl R., Eibl D., Eds.; John Wiley & Sons, Inc.: Hoboken, NJ, 2011; pp 21–32.
  2. 2.↵
    1. Eibl R.,
    2. Eibl D.
    1. Eibl D.,
    2. Peuker T.,
    3. Eibl R.
    Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction. In Single-Use Technology in Biopharmaceutical Manufacture, Eibl R., Eibl D., Eds.; John Wiley & Sons, Inc.: Hoboken, NJ, 2011; pp 3–11.
  3. 3.↵
    1. Cromwell M. E.,
    2. Hilario E.,
    3. Jacobson F.
    Protein aggregation and bioprocessing. AAPS J. 2006, 8 (3), E572–E579.
    OpenUrlCrossRefPubMedWeb of Science
  4. 4.↵
    1. Nayak A.,
    2. Colandene J.,
    3. Bradford V.,
    4. Perkins M.
    Characterization of subvisible particle formation during filling pump operation of a monoclonal antibody solution. J. Pharm. Sci. 2011, 100 (10), 4198–4204.
    OpenUrlPubMed
  5. 5.↵
    1. Tyagi A. K.,
    2. Randolph T. W.,
    3. Dong A.,
    4. Maloney K. E.,
    5. Hitscherich C. Jr..,
    6. Carpenter J. F.
    IgG particle formation during pump operation: A case study of heterogeneous nucleation on stainless steel nanoparticles. J. Pharm. Sci. 2009, 98 (1), 94–102.
    OpenUrlPubMed
  6. 6.↵
    1. Bee J. S.,
    2. Stevenson J. L.,
    3. Mehta B.,
    4. Svitel J.,
    5. Pollastrini J.,
    6. Platz R.,
    7. Freund E.,
    8. Carpenter J. F.,
    9. Randolph T. W.
    Response of a concentrated monoclonal antibody formulation to high shear. Biotechnol. Bioeng. 2009, 103 (5), 936–943.
    OpenUrlPubMed
  7. 7.↵
    1. Thomas C. R.,
    2. Geer D.
    Effect of shear on protein in solution. Biotechnol. Lett. 2011, 33 (3), 443–456.
    OpenUrlPubMed
  8. 8.↵
    1. Sinclair A.,
    2. Monge M.
    Evaluating disposable mixing systems. BioPharm International 2009, 22 (2).
  9. 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. 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. 11.↵
    Millipore website, Mobius® Disposable Mixing System User Guide, http://www.millipore.com/userguides.nsf/a73664f9f981af8c852569b9005b4eee/02505c45cc505b0d852575c90062ff4d/$FILE/00101867pu.pdf (accessed April 20, 2014).
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 2
March/April 2015
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Sign In to Email Alerts with your Email Address
Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
10 + 3 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
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

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
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
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results
    • Discussion
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgments
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations
  • Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress
  • Google Scholar

More in this TOC Section

  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
  • A Proof-of-Concept Study on a Universal Standard Kit to Evaluate the Risks of Inspectors for Their Foundational Ability of Visual Inspection of Injectable Drug Products
Show more Research

Similar Articles

Keywords

  • Bottom-mounted mixing
  • monoclonal antibody
  • Levitation mixer
  • Magnetic mixer
  • Disposables
  • Filter fouling
  • Particle formation

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire