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Brent Harlow

Brent Harlow

Brent Harlow has experience performing microbiological testing in the pharmaceutical industry since 2009. He joined Alcami in 2014 and has considerable experience in performing validation and suitability work for Microbial Limits Testing and Antimicrobial Effectiveness Testing and is the subject matter expert for Microbial Genetic Identification testing and Microbial In-Use Studies. Brent has a Bachelor of Science degree in Biology from the Ohio State University.

Recent Posts by Brent Harlow:

ON-DEMAND WEBINAR: The Importance of Microbial In-Use Studies

A microbial in-use (admixture) study is performed to evaluate the growth of low-level microorganisms inoculated into the diluted drug product and tested at several time points over the prescribed administration time. These studies are performed to determine if microbial growth will be supported and/or proliferate in the product during the holding period prior to patient administration in the event of inadvertent microbial contamination during product dilution. It is important to understand and comply with the timelines and deadlines surrounding these microbiological procedures. 

In this webinar, Alcami’s admixture studies expert, Brent Harlow, will guide you through the necessity of these studies and how to successfully perform them for FDA approval. 

Topics: Webinars Microbiology

The Top Eight Most Asked Questions about Microbial In-Use Studies

According to Dr. John Metcalfe, “pharmaceutical companies go to great lengths to manufacture a drug product which is sterile, whether by terminal sterilization or aseptic processing. Equally important to the microbiological quality of the product at the time of product release is its microbiological quality at the time of patient administration.” This Q & A featuring microbial in-use studies with microbiological expert, Brent Harlow, will address the most common questions asked about these studies.

Topics: Analytical Testing Microbiology