Search results for "contamination"
Article
Bioburden Control in the Biopharmaceutical Industry
Up-to-date lists of product recalls due to contamination by objectionable microorganisms are provided by FDA (1). The Center for Food Safety and Applied Nutrition (CFSAN)—under FDA—provided a comprehe…
Article
Putting Viral Clearance Capabilities to the Test
…irm expression construct stability, and to demonstrate the absence of potential bacterial and viral contamination. “Additional routine bulk harvest testing and the viral clearance study complete the …
Article
Regulatory Challenges in the QbD Paradigm
…luate process analytical technology and in-line or at-line sensors for early detection of microbial contamination. There is even the possibility of real-time release through the implementation of alt…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
…t qualification: Methodology and equipment/reagents tested for quality control and to minimize contamination risks.
Process qualification: All purification/isolation and processing steps sho…
Article
Best Practices for Selecting a Top-Quality Cell Line
…irect ways of determining clonality that makes it considerably easier to monitor drift and possible contaminations in production cell lines,” he remarks.
Moving toward multiparameter screening
…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
History of viral contaminations in commercial cell culture manufacturing processes.
For the sake of safety, there were also aggressive efforts to reduce the potential risks of viral conta…
Article
Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
Article
Viral Clearance Challenges in Bioprocessing
Upstream viral clearance
Using media with a low level of viral contamination can lead to major problems in biologics manufacturing. Cell-culture media and other raw materials, particularly those de…
Article
Moving PAT from Concept to Reality
Reducing the need for manual sampling lowers the risk of operator error and contamination, while the timely identification and correction of process irregularities will help minimize the risk of lost …
Article
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Analytical exoglycosidases are transitioning from being largely academic tools to being s…