Search results for " bioburden"
Article
Process Development: What May Lie Ahead in 2018?
Readers were very interested to learn how to prevent bioburden incidents in this article written by a former FDA BLA reviewer and inspector. Also hot was a second piece on protecting against microbiol…
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Current Innovations and Practices To Address Microbial Contamination in Downstream Bioprocessing
A multifaceted, collaborative approach is the key to addressing the multiple challenges of bioburden control. Improved ways of working in the manufacturing facility have been facilitated by supplier d…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Thus, good sanitation methods and familiarity with the most likely microbial contaminant species present in the immediate environment are needed to address bioburden. Using pre-sanitized single-use co…
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Reducing Cross-Contamination Risks in Process Chromatography
In addition, disposable flow-paths on single-use downstream processing equipment typically come gamma irradiated, leading to better bioburden control, according to Lundström. Preparatory and post-proc…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Now, 1M NaOH can in fact be used, improving the bioburden control, and the binding capacity is now up to 80 g/L. With an increased binding capacity and new high-flow agarose bead design, the productiv…
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Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
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Microbiological Testing: Time is of the Essence
…or ensuring sterility, determining antimicrobial effectiveness, detecting microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring programs. Growin…
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Aseptic Processing: Keeping it Safe
A concise environmental monitoring program can help a manufacturer assess product bioburden that may be attributable to water-derived organisms.
Operator interventions
The most common introduc…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
“Environmental monitoring of different rooms is necessary to ensure they stay within qualified requirements (temperature, pressure, humidity, bioburden, etc.) Some sampling is manual, but where possib…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
…idelines (6), extractable and leachable profiles using BPOG guidelines on single-use components, and bioburden and endotoxin specifications on validated processes to manufacture these concentrates ar…