Search results for " contamination" in Articles / App Notes
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Automation at this late-stage manufacturing step further reduces the risks of contamination, and most systems today, not including small manual operations, are typically highly automated. This has led…
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Reducing the Risk of RNAse Contamination in mRNA Production
LEARN MORE ABOUT REDUCING RNAse CONTAMINATION HERE >>
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Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
Manufacturers’ efforts to avoid microbial contamination are today being complemented by developments from bioprocessing suppliers.
A multifaceted, collaborative approach is the key to addressing t…
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Application of Quality by Design to Viral Safety
Recent and historic contamination events demonstrate the importance of the viral safety of raw materials. Porcine circovirus (1), murine minute virus (2), Cache Valley virus (3,4), and reovirus type 2…
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Ensuring the Biological Integrity of Raw Materials
Although contamination can occur from the cell culture itself or from labware and the laboratory environment, raw materials are the most significant source of contamination, which can lead to false re…
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Ensuring Viral Safety of Viral Vaccines and Vectors
However, because biological materials—cell substrates and often animal-derived products—are used in their manufacture, viral vaccines and vectors are at risk of contamination from micro-organisms, suc…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
…nant proteins, and monoclonal antibodies, is associated with the concomitant risk of process/product contamination with endogenous retroviruses, latent viruses, or new and emerging adventitious agent…
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Aseptic Processing: Keeping it Safe
Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such …
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Selecting a Comprehensive Bioburden Reduction Plan
Understanding potential sources of contamination for a given facility and manufacturing process is key to planning for design, preventative maintenance, bioburden monitoring, and remedial actions. Eff…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Microbial contamination of continuous cell cultures by a wide variety of microorganisms is also problematic in cell culture laboratories worldwide, particularly by mycoplasma. The latter can be diffic…