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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

Alcami Announces Industry-Leading Analytical Testing Turnaround Time

Durham, NC (USA) – May 8, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announces the advancement of the drug development process with the company’s new, dramatically-reduced analytical testing turnaround times. Alcami continues to set the industry standard with its analytical testing offering, and through operational excellence, streamlined processes, and technical knowledge and expertise, has reduced timelines by up to 30 percent.

“At Alcami, your timeline is our timeline,” said Alcami Chief Commercial Officer, Syed T. Husain. “We have made efficient, rapid, and reliable turnaround time a priority, as part of our commitment to bring our clients’ products through the clinic and to market first, while delivering the highest level of quality and finest customer experience in the industry.”

Topics: Company News Analytical Testing Development Microbiology Analytical Development

Filter Validation – An Interview with Stacey Ramsey

Joining Alcami in 2015, Stacey Ramsey, a senior scientist specialized in microbiology, is a scientific expert on microbial retention. Ramsey’s work focuses on the clinical stages of a drug product which compliments her experience in process development and method development in microbiology. Being part of the development process goes beyond running tests on lab samples, which allows Ramsey to showcase her passion while being a fundamental member of the Alcami development process team.

Q + A

How would you explain filter validation to someone outside of the pharmaceutical world?
From a big picture perspective, filter validation is filtering out microorganisms from a lab sample. In other words, it’s when you have a drug product that it is sterilized by means of a filter. In order to be able to filter out microorganisms, the filter has to have such small pores that it excludes bacteria and, therefore, you’re filtering out bacteria.

Topics: Thought Leadership Analytical Testing Filter Validation Microbiology