Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

Anita Bawa; Sofia Asefi; Stephanie Ramsey; Christine Arbesser-Rastburg; Mousumi Paul; Fran Leira; Tracy Landeryou; Bindhu Reddy; Marie Murphy; Barbara Daddis; David Bain

doi:10.5731/pdajpst.2016.007351

Article CommentaryCommentary

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis and David Bain

PDA Journal of Pharmaceutical Science and Technology September 2017, 71 (5) 413-420; DOI: https://doi.org/10.5731/pdajpst.2016.007351

Anita Bawa

Director, QC, Bayer, 800 Dwight Way, Berkeley, CA 94710, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Sofia Asefi

QC Senior Manager, Bayer, 800 Dwight Way, Berkeley, CA 94710, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Stephanie Ramsey

Manager Quality Systems, Shire 1 Baxter Way, Westlake Village, CA 91362, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Christine Arbesser-Rastburg

Director, Global Microbiology Shire, Industriestraße 67, 1220, Wien, Austria

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Mousumi Paul

Associate Director, Biologics Quality Operations, Merck, 770 Sumneytown Pike, West Point, PA 19486, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Fran Leira

Global MSAT/QC Head, Lonza La Relva s/n ES - 36400 Porrino

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Tracy Landeryou

Director QC Microbiology, Pfizer, 1 Burtt Rd, Andover, MA 01810, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Bindhu Reddy

QC Supervisor, AstraZeneca / MedImmune 1 Medimmune Way, Gaithersburg, MD 20878, USA

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Marie Murphy

Microbiologist, Biotechnology Operations, Eli Lilly, Hyde House Saint Kevin's 2vrm, 65 Adelaide Rd, Dublin, Ireland

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Barbara Daddis

Associate Director of Microbiological Control, Bristol-Myers Squibb, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08902

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

David Bain

Facilitator, BPOG, 5 Westbrook Court, Sharrowvale Rd, Sheffield S11 8YZ

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
References
Info & Metrics
PDF

Article Information

vol. 71 no. 5 413-420

DOI

https://doi.org/10.5731/pdajpst.2016.007351

PubMed

28624776

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 11, 2017.

Article Versions

previous version (June 16, 2017 - 18:59).
You are viewing the most recent version of this article.

Author Information

Cited By...

2 Citations
Google Scholar

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

Case study on the environmental monitoring for biological manufacturing using Time-lapse Shadow Image Analysis

Shoji Narutaki, Ineui Lee, Yasuhito Sugawara, Kahei Akada, Akihiko Kondo

Biologicals 2020 66
Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions

Courtney Russell, Niloufar Parsaei, David L Jones

EJPPS EUROPEAN JOURNAL OF PARENTERAL AND PHARMACEUTICAL SCIENCES 2020

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 71, Issue 5

September/October 2017

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 Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

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 * 10 + 0 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Bain

PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 413-420; DOI: 10.5731/pdajpst.2016.007351

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

Anita Bawa, Sofia Asefi, Stephanie Ramsey, Christine Arbesser-Rastburg, Mousumi Paul, Fran Leira, Tracy Landeryou, Bindhu Reddy, Marie Murphy, Barbara Daddis, David Bain

PDA Journal of Pharmaceutical Science and Technology Sep 2017, 71 (5) 413-420; DOI: 10.5731/pdajpst.2016.007351

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

No citing articles found.

Google Scholar

Main menu

User menu

Search

Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective

Article Information

Article Versions

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.