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 ArticlePDA Paper

Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products

Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson and Rick Watson
PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 123-139; DOI: https://doi.org/10.5731/pdajpst.2015.01037
Stan Bukofzer
MD
Roles: Hospira, Inc (Chair)
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: stan.bukofzer@hospira.com
John Ayres
MD
Roles: Eli Lilly and Company
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Anna Chavez
MD
Roles: Baxter
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Minerva Devera
DBA, QSM
Roles: Emergent
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Jahanvi Miller
MBA
Roles: Parenteral Drug Association (PDA)
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Douglas Ross
MD
Roles: Pfizer
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
John Shabushnig
PhD
Roles: Insight Pharma Consulting, LLC
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Susan Vargo
MS, PhD
Roles: Amgen
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Harry Watson
MTSC
Roles: CMQ/OE, Hospira, Inc
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Rick Watson
Roles: Merck
  • 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

Article Information

vol. 69 no. 1 123-139
DOI 
https://doi.org/10.5731/pdajpst.2015.01037
PubMed 
25691720

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 17, 2015.

Copyright & Usage 
© PDA, Inc. 2015

Author Information

Cited By...

  • 40 Citations
  • Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

  • Immunogenicity of Therapeutic Protein Aggregates
    Ehab M. Moussa, Jainik P. Panchal, Balakrishnan S. Moorthy, Janice S. Blum, Marisa K. Joubert, Linda O. Narhi, Elizabeth M. Topp
    Journal of Pharmaceutical Sciences 2016 105 2
  • Clinically established biodegradable long acting injectables: An industry perspective
    Christian Isalomboto Nkanga, Andreas Fisch, Mazda Rad-Malekshahi, Marieta Duvnjak Romic, Birgit Kittel, Thomas Ullrich, Jing Wang, Rui Werner Maçedo Krause, Sabine Adler, Twan Lammers, Wim E. Hennink, Farshad Ramazani
    Advanced Drug Delivery Reviews 2020 167
  • Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based Biotherapeutics
    Marisa K. Joubert, Meghana Deshpande, Jane Yang, Helen Reynolds, Christine Bryson, Mark Fogg, Matthew P. Baker, Jonathan Herskovitz, Theresa J. Goletz, Lei Zhou, Michael Moxness, Gregory C. Flynn, Linda O. Narhi, Vibha Jawa, Cheryl A. Stoddart
    PLOS ONE 2016 11 8
  • Evaluating the Role of the Air-Solution Interface on the Mechanism of Subvisible Particle Formation Caused by Mechanical Agitation for an IgG1 mAb
    Saba Ghazvini, Cavan Kalonia, David B. Volkin, Prajnaparamita Dhar
    Journal of Pharmaceutical Sciences 2016 105 5
  • Alleviating Drug Shortages: The Role of Mandated Reporting Induced Operational Transparency
    Junghee Lee, Hyun Seok (Huck) Lee, Hyoduk Shin, Vish Krishnan
    Management Science 2021 67 4
  • Particles in Biopharmaceutical Formulations, Part 2: An Update on Analytical Techniques and Applications for Therapeutic Proteins, Viruses, Vaccines and Cells
    Alexandra Roesch, Sarah Zölls, Daniela Stadler, Constanze Helbig, Klaus Wuchner, Gideon Kersten, Andrea Hawe, Wim Jiskoot, Tim Menzen
    Journal of Pharmaceutical Sciences 2022 111 4
  • Silicone Migration From Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions
    Stefanie Funke, Julia Matilainen, Heiko Nalenz, Karoline Bechtold-Peters, Hanns-Christian Mahler, Wolfgang Friess
    Journal of Pharmaceutical Sciences 2016 105 12
  • A Newly Identified Impurity in Polysorbate 80, the Long-Chain Ketone 12-Tricosanone, Forms Visible Particles in a Biopharmaceutical Drug Product
    Veronika Hampl, Xinghua Guo, Christian Ehrenstrasser, Martin Viertler, Lucy Rayner, Giusy Campanelli, Reinhard Schipflinger, Karine Thewes, Alessandra Cerreti, Stephan Boehm, Corinna Sonderegger
    Journal of Pharmaceutical Sciences 2018 107 6
  • Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products
    Markus Blümel, Jing Liu, Isabella de Jong, Sarah Weiser, Jonas Fast, Jennifer Litowski, Melissa Shuman, Shyam B. Mehta, Leanne Amery, David Cheng Thiam Tan, Feng Jia, Dushyant Shekhawat, Camille Dagallier, Mina Emamzadeh, Annette Medina, Camilla Santos, Florian Gasser, Christian Urban
    Journal of Pharmaceutical Sciences 2023 112 9
  • Cost of goods sold and total cost of delivery for oral and parenteral vaccine packaging formats
    Jeff Sedita, Stefanie Perrella, Matt Morio, Michael Berbari, Jui-Shan Hsu, Eugene Saxon, Courtney Jarrahian, Annie Rein-Weston, Darin Zehrung
    Vaccine 2018 36 12
  • Particulate Matter in Injectable Drugs: Evaluation of Risks to Patients
    Maxime Perez, Aurélie Maiguy-Foinard, Christine Barthélémy, Bertrand Décaudin, Pascal Odou
    Pharmaceutical Technology in Hospital Pharmacy 2016 1 2
  • Variance Between Different Light Obscuration and Flow Imaging Microscopy Instruments and the Impact of Instrument Calibration
    Anja Matter, Atanas Koulov, Satish Singh, Hanns-Christian Mahler, Helena Reinisch, Carolin Langer, Benjamin Zucol, Roman Mathaes
    Journal of Pharmaceutical Sciences 2019 108 7
  • Managing particulates in cell therapy: Guidance for best practice
    Dominic Clarke, Jean Stanton, Donald Powers, Ohad Karnieli, Sagi Nahum, Eytan Abraham, Jean-Sebastien Parisse, Steve Oh
    Cytotherapy 2016 18 9
  • Fatty Acids Can Induce the Formation of Proteinaceous Particles in Monoclonal Antibody Formulations
    Jingtao Zhang, Jiayi He, Katelyn J. Smith
    Journal of Pharmaceutical Sciences 2022 111 3
  • Population balance modelling of aggregation of monoclonal antibody based therapeutic proteins
    Rohit Bansal, Pulkit Srivastava, Anurag S. Rathore, Paresh Chokshi
    Chemical Engineering Science 2020 216
  • Evaluation of Particle Techniques for the Characterization of Subvisible Particles From Elastomeric Closure Components
    John Rech, Amber Fradkin, Aaron Krueger, Crystal Kraft, Diane Paskiet
    Journal of Pharmaceutical Sciences 2020 109 5
  • Forced degradation of cell-based medicinal products guided by flow imaging microscopy: Explorative studies with Jurkat cells
    A.D. Grabarek, W. Jiskoot, A. Hawe, K. Pike-Overzet, T. Menzen
    European Journal of Pharmaceutics and Biopharmaceutics 2021 167
  • Qualitative High-Throughput Analysis of Subvisible Particles in Biological Formulations Using Backgrounded Membrane Imaging
    Markela Ibo Murphy, Maria Bruque, Alexis Hanford, Isabelle Trayton, Melody Handali, Jesse A Leissa, Sathish Hasige, Katie Day, Sajal M Patel
    Journal of Pharmaceutical Sciences 2022 111 6
  • The quality of drugs and drug products – Always guaranteed?
    Helmut Buschmann, Norbert Handler, Ulrike Holzgrabe
    Journal of Pharmaceutical and Biomedical Analysis 2024 239
  • Method to Determine Syringe Silicone Oil Layer Heterogeneity and Investigation of its Impact on Product Particle Counts
    Michelle Cua, Daniel Martin, Patricia Meza, Gianni Torraca, Thomas Pearson, Shawn Cao, Changhuei Yang
    Journal of Pharmaceutical Sciences 2020 109 11
  • Pharmaceutical Foreign Particle Detection: An Efficient Method Based on Adaptive Convolution and Multiscale Attention
    Junfei Yi, Hui Zhang, Jianxu Mao, Yurong Chen, Hang Zhong, Yaonan Wang
    IEEE Transactions on Emerging Topics in Computational Intelligence 2022 6 6
  • Effect of Technically Relevant X-Ray Doses on the Structure and Function of Alcohol Dehydrogenase and Hen Egg-White Lysozyme
    Lisa-Marie Schaden, Miriam Wimmer-Teubenbacher, Johannes Poms, Peter Laggner, Karl Lohner, Stephan Sacher, Johannes G. Khinast, Sharareh Salar-Behzadi
    Pharmaceutical Research 2018 35 7
  • The need for new control strategies for particulate matter in parenterals
    Johannes Poms, Stephan Sacher, Matthias Nixdorf, Michael Dekner, Sabine Wallner-Mang, Ines Janssen, Johannes G. Khinast, Robert Schennach
    Pharmaceutical Development and Technology 2019 24 6
  • An Interlaboratory Study to Identify Potential Visible Protein-Like Particle Standards
    Srivalli N. Telikepalli, Michael J. Carrier, Dean C. Ripple, Greg Barnett, Ashwinkumar Bhirde, Donna Bolton, George M. Bou-Assaf, Erica Ferrari, Scott Leigh, Sophia Levitskaya-Seaman, Tim Menzen, Felix Nikels, Anna Riley, Miguel Saggu, Neha Sahni, Eric Vernooij, Klaus Wuchner
    AAPS PharmSciTech 2022 24 1
  • Human Serum Albumin Mitigates Formation of Fatty Acid Particles in Polysorbate-Containing Solutions
    Dorothy M. Kim, Kensey Stansberry-Perkins, Michael S. Marlow, Erica A. Pyles
    Journal of Pharmaceutical Sciences 2022 111 11
  • On the drivers of drug shortages: empirical evidence from Germany
    David Francas, Stephan Mohr, Kai Hoberg
    International Journal of Operations & Production Management 2023 43 10
  • Stability of Protein Pharmaceuticals: Recent Advances
    Mark Cornell Manning, Ryan E. Holcomb, Robert W. Payne, Joshua M. Stillahn, Brian D. Connolly, Derrick S. Katayama, Hongcheng Liu, James E. Matsuura, Brian M. Murphy, Charles S. Henry, Daan J. A. Crommelin
    Pharmaceutical Research 2024 41 7
  • Visible particles in parenteral drug products: A review of current safety assessment practice
    Frank Liu, Richard Hutchinson
    Current Research in Toxicology 2024 7
  • Particulates are everywhere, but are they harmful in cell and gene therapies?
    Samuel A. Molina, Stephanie J. Davies, Dalip Sethi, Steve Oh, Nisha Durand, Michael Scott, Lindsay C. Davies, Klaus Wormuth, Dominic Clarke
    Cytotherapy 2022 24 12
  • An Intra-Company Analysis of Inherent Particles in Biologicals Shapes the Protein Particle Mitigation Strategy Across Development Stages
    Sorina Morar-Mitrica, Thomas Pohl, Dietmar Theisen, Björn Boll, Karoline Bechtold-Peters, Reinhard Schipflinger, Beate Beyer, Swen Zierow, Michael Kammüller, Andreas Pribil, Bernhard Schmelzer, Stephan Boehm, Micheline Goetti, Tim Serno
    Journal of Pharmaceutical Sciences 2023 112 5
  • Alleviating Drug Shortages: The Role of Mandated Reporting-Induced Operational Transparency
    Junghee Lee, Hyun Seok Lee, Hyoduk Shin, Vish Krishnan
    SSRN Electronic Journal 2020
  • Biosimilars
    Aaron B. Krueger, Matthew D. Brown
    2018 34
  • Safety assessment of drug impurities for patient safety: A comprehensive review
    Frank Liu
    Regulatory Toxicology and Pharmacology 2024 153
  • Vial coring and fragmentation incidence after angled penetration of rubber stoppers with single-use hypodermic needles
    Marissa Rase, Mark Hanlon, Le Ho, Doug Duriez, Cathy Zhao
    Pharmaceutical Technology in Hospital Pharmacy 2021 6 1
  • Establishing a Platform Method for Physical Appearance Assessment of New Parenteral Pharmaceuticals
    Ying Wan, Walter Wasylaschuk, Joseph Straub, Wei Xu, Nicole Lepo, Patricia M. Egan, Jillian Acevedo-Skrip, Elizabeth Thoryk, Megan Mackey
    The AAPS Journal 2025 27 3
  • Impact of vial quality on interactions, particle formation, container closure integrity, and gas permeability for frozen drug product storage
    Daniela Henle, Lukas Muehlfeld, Daniel Molnar, Patrick Garidel, Wolfgang Friess
    European Journal of Pharmaceutical Sciences 2025 206
  • Literature review: The role of particle size distribution in drug delivery
    Ahmad Ainurofiq, Ardelia Abidah Suryanto, Bunga Seftya Beltiartono, Nur Ainun Merdekawati, Nur Putri Ardiyani, Queenniken Yuliana Chandra Farohma, Arif Budiman, Yoga Windhu Wardhana, Yuda Prasetya Nugraha
    Multidisciplinary Reviews 2025 8 9
  • Parenteral İlaçlardaki Gizli Tehdit: Cam Partikül Kontaminasyonu
    Nida Nur SÖĞÜT, Arzu ERKOÇ HUT
    Gümüşhane Üniversitesi Sağlık Bilimleri Dergisi 2022 11 3
  • Pattern Recognition
    Gabriele Rosati, Kevin Marchesini, Luca Lumetti, Federica Sartori, Beatrice Balboni, Filippo Begarani, Luca Vescovi, Federico Bolelli, Costantino Grana
    2025 15317
  • Production of Hydrophobic Microparticles at Safe-To-Inject Sizes for Intravascular Administration
    Francisca L. Gomes, Francisco Conceição, Liliana Moreira Teixeira, Jeroen Leijten, Pascal Jonkheijm
    Pharmaceutics 2025 17 1
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (1)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 1
January/February 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.
Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
(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.
5 + 12 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 123-139; DOI: 10.5731/pdajpst.2015.01037

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Share
Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products
Stan Bukofzer, John Ayres, Anna Chavez, Minerva Devera, Jahanvi Miller, Douglas Ross, John Shabushnig, Susan Vargo, Harry Watson, Rick Watson
PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 123-139; DOI: 10.5731/pdajpst.2015.01037
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget
  • Facebook Like
  • Google Plus One

Jump to section

  • Article
    • Executive Summary
    • Introduction
    • Current Defined Rules
    • Evolving Stances and Drivers
    • Particle Matter Consideration
    • Particle Size
    • Pathophysiological Considerations and Clinical Implications
    • Risk Assessment
    • Quality Risk Management
    • Conclusion: Overall Medical Risk
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • 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
  • Identification and Root Cause Analysis of the Visible Particles Commonly Encountered in the Biopharmaceutical Industry
  • Applying Machine Learning to the Visual Inspection of Filled Injectable Drug Products
  • Points to Consider: Best Practices to Identify Particle Entry Routes along the Manufacturing Process for Parenteral Formulations
  • Development of Protein-Like Reference Material for Semiquantitatively Monitoring Visible Proteinaceous Particles in Biopharmaceuticals
  • Achieving "Zero" Defects for Visible Particles in Injectables
  • Particulate Generation Mechanisms during Bulk Filling and Mitigation via New Glass Vial
  • A Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products
  • Semi-Quantitative Analysis of Inherent Visible Particles for Biopharmaceutical Products
  • Filtration of Glass Delamination Particles with West Pharmaceutical Vial Adapters
  • Google Scholar

More in this TOC Section

  • Case Studies on Changes and Proposed Process Development Approaches Reflecting Applicability of PDA Technical Report No. 89: Strategies for Vaccine Development and Lifecycle Management
  • Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
  • Controls to Minimize Disruption of the Pharmaceutical Supply Chain During the COVID-19 Pandemic
Show more PDA Paper

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