U.S. Food and Drug Administration

7 ARTICLES PUBLISHED IN JoVE

Environment

Detection of Foodborne Bacterial Pathogens from Individual Filth Flies

Monica Pava-Ripoll¹, Rachel E.G. Pearson¹, Amy K. Miller¹, George C. Ziobro¹

¹Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration

A PCR-based protocol was adapted to detect Cronobacter spp., Salmonella enterica, and Listeria monocytogenes from body surfaces and alimentary canals of individual wild-caught flies. The goal of this protocol is to detect and isolate bacterial pathogens from individual insects collected as part of an environmental sampling program during foodborne outbreak investigations.

Engineering

Scanning Light Scattering Profiler (SLPS) Based Methodology to Quantitatively Evaluate Forward and Backward Light Scattering from Intraocular Lenses

Bennett N. Walker¹, Robert H. James², Don Calogero¹, Ilko K. Ilev²

¹Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, ²Optical Therapeutics and Medical Nanophotonics Laboratory, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration

This protocol describes the scanning light scattering profiler (SLSP) that enables the full-angle quantitative evaluation of forward and backward scattering of light from intraocular lenses (IOLs) using goniophotometer principles.

Bioengineering

Use of High-Throughput Automated Microbioreactor System for Production of Model IgG1 in CHO Cells

Sai Rashmika Velugula-Yellela¹, Casey Kohnhorst¹, David N. Powers¹, Nicholas Trunfio¹, Anneliese Faustino¹, Phillip Angart¹, Erica Berilla¹, Talia Faison¹, Cyrus Agarabi¹

¹Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II, U.S. Food and Drug Administration

A detailed protocol for the concurrent operation of 48 parallel cell cultures under varied conditions in a microbioreactor system is presented. Cell culture process, harvest and subsequent antibody titer analysis are described.

Bioengineering

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Sai Rashmika Velugula-Yellela¹, David N. Powers¹, Phillip Angart¹, Anneliese Faustino¹, Talia Faison¹, Casey Kohnhorst¹, Erica J. Fratz-Berilla¹, Cyrus D. Agarabi¹

¹Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II, U.S. Food and Drug Administration

A detailed protocol for the purification and subsequent analysis of a monoclonal antibody from harvested cell culture fluid (HCCF) of automated microbioreactors has been described. Use of analytics to determine critical quality attributes (CQAs) and maximizing limited sample volume to extract vital information is also presented.

Bioengineering

Primary Clarification of CHO Harvested Cell Culture Fluid using an Acoustic Separator

Jin Sung Hong¹, Nicole Azer¹, Cyrus Agarabi¹, Erica J. Fratz-Berilla¹

¹Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II, U.S. Food and Drug Administration

Presented here is a protocol for the primary clarification of CHO cell culture using an acoustic separator. This protocol can be used for the primary clarification of shake flask cultures or bioreactor harvests and has the potential application for continuous clarification of the cell bleed material during perfusion bioreactor operations.

Biology

Loop-Mediated Isothermal Amplification for Screening Salmonella in Animal Food and Confirming Salmonella from Culture Isolation

Kelly J. Domesle¹, Shenia R. Young¹, Qianru Yang¹, Beilei Ge¹

¹Center for Veterinary Medicine, U.S. Food and Drug Administration

Loop-mediated isothermal amplification (LAMP) is an isothermal nucleic acid amplification test (iNAAT) that has attracted broad interest in the pathogen detection field. Here, we present a multi-laboratory-validated Salmonella LAMP protocol as a rapid, reliable, and robust method for screening Salmonella in animal food and confirming presumptive Salmonella from culture isolation.

Bioengineering

Evaluation of Cardiac Contractility Modulation Therapy in 2D Human Stem Cell-Derived Cardiomyocytes

Tromondae K. Feaster¹, Maura Casciola¹, Akshay Narkar¹, Ksenia Blinova¹

¹Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Here, we demonstrate a non-invasive cardiac medical device contractility evaluation method using 2D human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) monolayers, plated on a flexible substrate, coupled with video-based microscopy. This tool will be useful for the in vitro evaluation of the contractile properties of cardiac electrophysiology devices.