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

doi:10.5731/pdajpst.2015.01037

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

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

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

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

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

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.

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
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
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
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
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
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
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
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
Visible particles in parenteral drug products: A review of current safety assessment practice

Frank Liu, Richard Hutchinson

Current Research in Toxicology 2024 7
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
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
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
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

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 69, Issue 1

January/February 2015

Table of Contents
Index by Author

Download PDF

Article Alerts

User Name *

Password *

Email *

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.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following Industry Perspective on the Medical Risk of Visible Particles in Injectable Drug Products

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 4 + 9 =

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

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

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
Figures & Data
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

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

Main menu

User menu

Search

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

Article Information

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.