Search results for " microbial contamination"
Article
Best Practices for Selecting a Top-Quality Cell Line
…erted in the right location in the genome with the right dosage, and that the cell line is free from microbial contamination,” he explains.
As a result, a high-quality CAR-T-cell line should n…
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Defining Risk Assessment of Aseptic Processes
Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the assessment of risk in the processing of intravenous injectable drugs.
By Susan J. Schniepp
Q: I work in …
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…uring compared with solid-dosage manufacturing?
AstraZeneca: In biopharmaceutical manufacturing, microbial contamination is usually the greatest overall risk. The primary factors that affect the …
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Moving PAT from Concept to Reality
Although a difficult problem to solve, sensors that rapidly measure viral and microbial contamination are needed the most, Braatz states. The long (28-day) time to receive results from cell-culture-ba…
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Fluid Handling in Biopharma Facilities
Industry experts discuss challenges, trends, and innovations in fluid handling.
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling…
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A Look Ahead at BioPharma Manufacturing and Regulation
MICROBIAL CONTAMINATION
BioPharm: Priority 3 of the August 2011 strategic plan calls for reducing microbial contamination of medical products. What specific goals does FDA have in this area?
…
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Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Sources of Bioburden You Might Have Missed
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
The risk …
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Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API.
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…
Article
Trends in Single-use Bioreactors
Representatives from industry supplier companies address innovations, reliability, barriers to adoption, and the role of singIe-use bioreactors in bioprocessing.
By: Randi Hernandez
Whil…