Search results for " equipment" in Articles / App Notes
Article
Lessons Learned Accelerate Vaccine Development
The production and development teams worked very closely together, and there was also extensive collaboration with external partners, including raw material and equipment suppliers, contract partner I…
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Tools for Continuous Bioprocessing Development
• Equipment is being miniaturized for controlling DO and pH (9, 10) by integrating optical pH and DO sensors with 24-well plates and sparging oxygen and carbon dioxide through a permeable membrane at …
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Biopharma in 2015: A Year for Approvals and Innovations
A paper on process economic comparison between fermentation in single-use versus stainless steel equipment on PDF was well received.
This year, PDF will continue to report on drug approvals, innova…
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Best Practices in Qualification of Single-Use Systems
Technical Considerations: Chemical Compatibility
Unlike traditional stainless-steel equipment, SUS is generally made from polymers including plastics and elastomers. These polymers are obtained th…
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Biopharma Advances Demand Specialized Expertise
Lively (PPD): Evolving characterization expectations for biologics have driven improvements in analytical equipment, processes, and systems. Ultra performance liquid chromatography (UPLC) systems have…
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Ensuring the Quality of Biologicals
These general chapters give requirements for equipment and equipment verification and instructions on how to perform a method, such as peptide mapping. Ph. Eur. monographs and general chapters for bio…
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Improving PAT for Biologics
…ty of raw materials (particularly living organisms), and the move from stainless-steel to single-use equipment. The recent emphasis on establishing a thorough understanding of the manufacturing proce…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Two otherwise identically configured runs may produce slightly different responses due to changes in environment, equipment, measurement, sampling, and operators, among others. Even deliberately fixed…
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The Lifecycle Change of Process Validation and Analytical Testing
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APPLYING PAT
BioPharm: How may a given manufacturing process (including equipment design and operation) and analytical testing need to be modified to accommodate this lifecycle app…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
In general, having a mechanistic model in place that can be used to run in silico predictions anytime, anywhere without the need of lab equipment is a big advantage and proved especially valuable duri…