Search results for " sterile"
Article
Best Practices in Qualification of Single-Use Systems
Final drug-product sterile filtration and transfer using SUS has also being increasingly applied to fill/finish operations.
Figure 1: Typical mAb manufacturing process.
The implementation of …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Chromatography resins, for example, are not typically provided sterile or capable of being sterilized, so they are a potential source of contaminations unless cleaned, sanitized, and stored correctly.…
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Achieving Process Balance with Perfusion Bioreactors
The choice of the cell retention system, its filter pore size, and its integration or sterile connection to the bioreactor are of fundamental importance for all types of perfusion processes, agrees Th…
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Bioburden Control in the Biopharmaceutical Industry
Field, “Bioburden Control at the Sterile Filtration Step: A Risk-Based Approach,” presentation to European Biopharmaceutical Enterprises (May 2013).
10. Critical Process Filtration Inc., “Partic…
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Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
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Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
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The New World of Biopharmaceutical Manufacturing
Galliher, chief technology officer, Upstream, Cytiva; Sabrina Restrepo, associate director in the Sterile & Validation Center of Excellence, Global Technical Operations at Merck; Helene Pora, PhD, vic…
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Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
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Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
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Tools for Continuous Bioprocessing Development
It requires long-term cultures, and places greater stress on sterile interfaces for the continuous in-flow and out-flow of medium and cells.
For continuous perfusion processes to be efficient, the …