Search results for " monitoring" in Articles / App Notes
Article
Reimagining Affordable Biosimilars
Post-approval monitoring of the performance of the product is accomplished via pharmacovigilance. Given this arduous journey from lab to market, it is no surprise that biologics demand significant inv…
Article
Technology Innovations Improve Process Chromatography Performance
When everything blends and your monitoring is in-line, you become aware of the problem very quickly, but making that separation of what is affected or unaffected is crucial. You almost need second-ord…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
…hoods as well as through the use of closed culturing systems and automated, inline quality attribute monitoring.
Contamination isn’t the only risk to starting material quality. Cells are capabl…
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Emerging Therapies Test Existing Bioanalytical Methods
The technology allows for real-time monitoring of the cell therapy in vivo and can support the qPCR data for PK. Flow panels can be designed to evaluate the expression and persistence of the construct…
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Automating the Biomanufacturing Process
For example, a real-time monitoring system can extract data and use a statistical model to create user-friendly process trajectories that show process consistency. In this example, operators can use t…
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Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
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Achieving Process Balance with Perfusion Bioreactors
Equipment suppliers are responding to needs for more durable reactors and sensors, a greater variety of monitoring technologies, and bioreactors that can integrate with cell retention devices.
Per…
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Scaling Up Novel Therapies
“Not only strong process monitoring and control, but highly relevant assays are needed to ensure that clinically relevant product specifications are met. Where these are on-line or at-line, a high deg…
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Automation Trend in Fill/Finish Reduces Contamination Risk
Adopting automation
Typically, automated systems incorporate blow/fill/seal operations, dosing, environmental monitoring filling machines that use tool-less changeovers, in-process weight checks, s…
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Understanding Validation and Technical Transfer, Part 3
During the implementation and commercial manufacturing phases, engineering designs are finalized, equipment is qualified, processes validation studies are finalized, and ultimately continuous process …