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Published on: August 24, 2015
Risk reduction in biotherapeutic products
Charles R Ill1, Houman Dehghani
1Process & Product Development, Pilot & Cellular Resources, Amgen Inc, One Amgen Center Drive, Thousand Oaks, CA 91320, USA. cill@amgen.com
Current Opinion in Drug Discovery & Development
|April 1, 2009
Summary
This review highlights advances in rapid and accurate pathogen detection for biotherapeutics. Improved methods ensure patient safety by identifying and removing contaminants in biological products.
Area of Science:
- Biopharmaceutical Manufacturing
- Microbiology
- Regulatory Science
Background:
- Ensuring the safety of biological therapeutics is critical.
- Contaminating pathogens pose a significant risk to patients.
- Current detection methods can be time-consuming, delaying product release.
Purpose of the Study:
- To review current practices and emerging technologies for pathogen detection in biotherapeutics.
- To highlight advancements that improve the speed and accuracy of pathogen identification.
- To discuss strategies for mitigating risks associated with microbial contamination.
Main Methods:
- Review of recent literature on pathogen detection technologies.
- Analysis of industry practices for screening and testing biotherapeutic products.
- Evaluation of microbe clearance during purification processes.
Main Results:
- Recent advancements have accelerated pathogen detection and identification timelines.
- Multifaceted industry approaches include rigorous screening of raw materials and products.
- Technological improvements enhance the accuracy of adventitious and known microbial species detection.
Conclusions:
- Accelerated and accurate pathogen detection is crucial for biotherapeutic safety.
- Continuous improvement of detection and inactivation methods is essential.
- Comprehensive safety strategies mitigate risks to patients receiving biotherapeutic treatments.
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