RT Journal Article
SR Electronic
T1 Detection of Adventitious Viruses from Biologicals Using a Broad-Spectrum Microbial Detection Array
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 668
OP 674
DO 10.5731/pdajpst.2011.00838
VO 65
IS 6
A1 Crystal Jaing
A1 Shea Gardner
A1 Kevin McLoughlin
A1 James B. Thissen
A1 Tom Slezak
YR 2011
UL http://journal.pda.org/content/65/6/668.abstract
AB CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1–3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) We designed the Lawrence Livermore Microbial Detection Array (LLMDA), which contains 388,000 DNA probes. This array can detect any sequenced viruses or bacteria within 24 h. In addition, the oligonucleotide probes were selected to enable detection of novel, divergent species with homology to sequenced organisms. We recently used this array to identify an adventitious virus from a vaccine product. We have also used this array to detect viral and bacterial infections from various human clinical samples. Broad-spectrum microbial detection microarrays are efficient and cost-effective tools to rapidly screen cell bank samples, raw materials, vaccine samples, and clinical samples to ensure drug, food, and health safety in the United States and worldwide.