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

Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes

Wei Liu, Rob Swift, Gianni Torraca, Yasser Nashed-Samuel, Zai-Qing Wen, Yijia Jiang, Aylin Vance, Anthony Mire-Sluis, Erwin Freund, Janice Davis and Linda Narhi
PDA Journal of Pharmaceutical Science and Technology January 2010, 64 (1) 11-19;
Wei Liu
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rob Swift
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gianni Torraca
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yasser Nashed-Samuel
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Zai-Qing Wen
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yijia Jiang
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Aylin Vance
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Anthony Mire-Sluis
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Erwin Freund
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Janice Davis
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Linda Narhi
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

References

  1. 1.↵
    1. Shire S. J.,
    2. Shahrokh Z.,
    3. Liu J.
    Challenges in the development of high protein concentration formulations. J. Pharm. Sci. 2004, 93 ( 6), 1390– 1402.
    OpenUrlCrossRefPubMedWeb of Science
  2. 2.↵
    1. Harn N.,
    2. Allan C.,
    3. Oliver C.,
    4. Middaugh C. R.
    Highly concentrated monoclonal antibody solutions: direct analysis of physical structure and thermal stability. J. Pharm. Sci. 2007, 96 ( 3), 532– 546.
    OpenUrlPubMed
  3. 3.↵
    1. Cromwell M. E. M.,
    2. Hilario E.,
    3. Jacobson F.
    Protein aggregation and bioprocessing. AAPS J. 2006, 8 ( 3), E572– E579.
    OpenUrlCrossRefPubMedWeb of Science
  4. 4.↵
    1. Chi E. Y.,
    2. Krishnan S.,
    3. Randolph T. W.,
    4. Carpenter J. F.
    Physical stability of proteins in aqueous solution: mechanism and driving forces in non-native protein aggregation. Pharm. Res. 2003, 20 ( 9), 1325– 1336.
    OpenUrlCrossRefPubMedWeb of Science
  5. 5.↵
    1. Harrison B.,
    2. Rios M.
    Big Shot: developments in pre-filled syringes. Pharm. Technol. 2007, 31 ( 3), 50– 56.
    OpenUrl
  6. 6.↵
    1. Walsh G.
    Biopharmaceutical benchmarks. Nature Biotechnol. 2006, 24 ( 7), 769– 776.
    OpenUrlCrossRefPubMedWeb of Science
  7. 7.↵
    1. Overcashier D.,
    2. Chan E.,
    3. Hsu C.
    Technical considerations in the development of prefilled syringes for protein products. Am. Pharm. Rev. 2006, 9, 77– 83.
    OpenUrl
  8. 8.↵
    1. Goldstein J.,
    2. Newbury D.,
    3. Joy D.,
    4. Lyman C.,
    5. Echlin P.,
    6. Lifshin E.,
    7. Sawyer L.,
    8. Michael J.
    Scanning Electron Microscopy and X-Ray Microanalysis, 3rd ed., Springer Science + Business Media; New York, 2003.
  9. 9.↵
    Sadtler Database—IR—Sadtler Inorganics Bio-Rad Laboratories©. 1980; 1981– 2007.
  10. 10.↵
    1. Jiang Y.,
    2. Nashed-Samuel Y.,
    3. Li C.,
    4. Liu W.,
    5. Pollastrini J.,
    6. Mallard D.,
    7. Wen Z.,
    8. Fujimori K.,
    9. Pallitto M.,
    10. Donahue L.,
    11. Chu G.,
    12. Torraca G.,
    13. Vance A.,
    14. Mire-Sluis T.,
    15. Freund E.,
    16. Davis J.,
    17. Narhi L.
    Tungsten-induced protein aggregation II: solution behavior. J. Pharm. Sci. ( in press).
  11. 11.↵
    1. Miller J. N.,
    2. Miller J. C.
    Statistics and Chemometrics for Analytical Chemistry, 4th ed., Prentice Hall; U.K., 2000.
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 64 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 64, Issue 1
January/February 2010
  • 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.
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
(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.
7 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
Wei Liu, Rob Swift, Gianni Torraca, Yasser Nashed-Samuel, Zai-Qing Wen, Yijia Jiang, Aylin Vance, Anthony Mire-Sluis, Erwin Freund, Janice Davis, Linda Narhi
PDA Journal of Pharmaceutical Science and Technology Jan 2010, 64 (1) 11-19;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes
Wei Liu, Rob Swift, Gianni Torraca, Yasser Nashed-Samuel, Zai-Qing Wen, Yijia Jiang, Aylin Vance, Anthony Mire-Sluis, Erwin Freund, Janice Davis, Linda Narhi
PDA Journal of Pharmaceutical Science and Technology Jan 2010, 64 (1) 11-19;
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Abstract
    • 1. Introduction
    • 2. Materials and Methods
    • 3. Results and Discussion
    • 4. Conclusions
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
  • A Comparison of Protein Stability in Prefillable Syringes Made of Glass and Plastic
  • Characterization of Protein Aggregating Tungstates: Electrospray Mass Spectrometry Analysis of Extracts from Prefilled Syringes and from Tungsten Pins Used in the Manufacture of Syringes
  • Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products
  • Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products
  • Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
  • Development of an Inductively Coupled Plasma Mass Spectrometry Method for Quantification of Extracted Tungsten from Glass Prefilled Syringes Used as a Primary Packaging for Pharmaceutical and Therapeutic Protein Products
  • Inhibition of Tungsten-Induced Protein Aggregation by Cetyl Trimethyl Ammonium Bromide
  • Google Scholar

More in this TOC Section

  • 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
  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
Show more Research

Similar Articles

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