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

Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers

Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver and Sally Kline
PDA Journal of Pharmaceutical Science and Technology March 2013, 67 (2) 123-134; DOI: https://doi.org/10.5731/pdajpst.2013.00905
Matthew Hammond
‡Product Attribute Sciences;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: mhammond@amgen.com
Heather Nunn
§Cell Sciences & Technology, Amgen Inc., Seattle, WA; and
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Gary Rogers
‡Product Attribute Sciences;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Hans Lee
|Product Contact Assessment;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Anatolia-Liliana Marghitoiu
|Product Contact Assessment;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Lourdes Perez
|Product Contact Assessment;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Yasser Nashed-Samuel
|Product Contact Assessment;
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Carl Anderson
∧Pilot Plant Operations, Amgen Inc., Bothell, WA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Michael Vandiver
∧Pilot Plant Operations, Amgen Inc., Bothell, WA
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Sally Kline
†Materials Science, Amgen Inc., Thousand Oaks, CA;
  • 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

Note to pda.org users

The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.

Log in using your username and password

Forgot your user name or password?

Log in through your institution

You may be able to gain access using your login credentials for your institution. Contact your library if you do not have a username and password.
If your organization uses OpenAthens, you can log in using your OpenAthens username and password. To check if your institution is supported, please see this list. Contact your library for more details.

Purchase access

You may purchase access to this article. This will require you to create an account if you don't already have one.

patientACCESS

patientACCESS - Patients desiring access to articles

Full issue PDFs are for PDA members only. You can join PDA at www.pda.org. 

PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 2
March/April 2013
  • 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.
Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers
(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.
1 + 0 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers
Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver, Sally Kline
PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 123-134; DOI: 10.5731/pdajpst.2013.00905

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Identification of a Leachable Compound Detrimental to Cell Growth in Single-Use Bioprocess Containers
Matthew Hammond, Heather Nunn, Gary Rogers, Hans Lee, Anatolia-Liliana Marghitoiu, Lourdes Perez, Yasser Nashed-Samuel, Carl Anderson, Michael Vandiver, Sally Kline
PDA Journal of Pharmaceutical Science and Technology Mar 2013, 67 (2) 123-134; DOI: 10.5731/pdajpst.2013.00905
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

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

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes
  • A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization
  • Investigation of Air-Liquid Interface Rings in Buffer Preparation Vessels: the Role of Slip Agents
  • 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
  • Extractables Analysis of Single-Use Flexible Plastic Biocontainers
  • 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

Keywords

  • Bioprocess container
  • Extractables
  • Leachables
  • Cell growth
  • Polyethylene
  • Irgafos

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