Search results for " aseptic" in Articles / App Notes
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
“Although barrier isolation technology provides the highest level of aseptic processing, long bio-decontamination cycle times remain one of the biggest challenges for achieving a rapid changeover,” he…
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Improving Upstream Predictability
Integrated systems will be needed to aseptically connect upstream and downstream so that the entire process operates as a closed system, he says. Typically, this has been done by adding aseptic connec…
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Tools and Processes for Mature and Emerging Therapies
New technologies for aseptic processing—a frequent source of quality problems—were in evidence at INTERPHEX. To control contamination threats during transfer and fill/finish steps for bulk, vial, and …
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Efficient concentration of a low-titer bovine IgG with high recovery in low volume
The use of ReadyCircuit™ single-use assemblies allowed for aseptic connectivity of the filtration device. Filtration was performed using ReadyToProcess™ hollow fiber filter cartridges. The described …
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Perfusion in the 21st Century
Equipment limitations, such as the lack of good aseptic connectors, marginal pump accuracy, and inadequate on-line monitoring, led to technical problems and regulatory uncertainties. There were questi…
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Operational Excellence: More Than Just Process Improvement
Because a significant amount of deviations were also related to positive EM test results, the quality and site sterility assurance groups worked to improve aseptic practices.
The resulting gains in…
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Accelerating time to market through process innovation
Topics include:
- Next generation upstream process enablers
- Developing continuous downstream processing
- Aseptic filling
View the agenda and register here
Article
Maximum Output Starts with Optimized Upstream Processing
He also notes that aseptic filling of biologics, in particular live virus filling, is one of the most critical bottlenecks in the biopharma development and manufacturing process, including availabilit…
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Genetic Vaccine Platforms Demonstrate Their Potential
In addition, both traditional and genetic vaccines require filling under aseptic conditions, further reducing global capacity.
Stability and delivery hurdles, too
…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
…e case of autologous therapies and the highly manual, and often open, nature of processing requiring aseptic processing operations, Ramaswamy explains. “Facilities are commonly grade B cleanrooms wit…