Mold Control and Detection in Biological Drug Substance Manufacturing Facilities: An Industry Perspective
PDA J Pharm Sci Technol
.
2017 Sep-Oct;71(5):413-420.
doi: 10.5731/pdajpst.2016.007351.
Epub 2017 Jun 16.
Authors
Anita Bawa
1
,
Sofia Asefi
2
,
Stephanie Ramsey
3
,
Christine Arbesser-Rastburg
4
,
Mousumi Paul
5
,
Fran Leira
6
,
Tracy Landeryou
7
,
Bindhu Reddy
8
,
Marie Murphy
9
,
Barbara Daddis
10
,
David Bain
11
Affiliations
1
Director, QC, Bayer, 800 Dwight Way, Berkeley, CA 94710, USA.
2
QC Senior Manager, Bayer, 800 Dwight Way, Berkeley, CA 94710, USA.
3
Manager Quality Systems, Shire 1 Baxter Way, Westlake Village, CA 91362, USA.
4
Director, Global Microbiology Shire, Industriestraße 67, 1220, Wien, Austria.
5
Associate Director, Biologics Quality Operations, Merck, 770 Sumneytown Pike, West Point, PA 19486, USA.
6
Global MSAT/QC Head, Lonza La Relva s/n ES - 36400 Porrino.
7
Director QC Microbiology, Pfizer, 1 Burtt Rd, Andover, MA 01810, USA.
8
QC Supervisor, AstraZeneca / MedImmune 1 Medimmune Way, Gaithersburg, MD 20878, USA.
9
Microbiologist, Biotechnology Operations, Eli Lilly, Hyde House Saint Kevin's 2vrm, 65 Adelaide Rd, Dublin, Ireland.
10
Associate Director of Microbiological Control, Bristol-Myers Squibb, Bristol-Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ 08902.
11
Facilitator, BPOG, 5 Westbrook Court, Sharrowvale Rd, Sheffield S11 8YZ.
PMID:
28624776
DOI:
10.5731/pdajpst.2016.007351
No abstract available
MeSH terms
Biological Products / standards*
Drug Industry / standards*
Fungi / isolation & purification*
Humans
Manufacturing and Industrial Facilities / standards
Substances
Biological Products