Search results for " equipment" in Articles / App Notes
Article
Technologies and Practices Must Evolve to Meet Demand
Spending on biopharmaceutical manufacturing equipment and services was up compared to 2013; 52.5% reported an increase in spending compared to 2013 (37.8%). The optimistic outlook continues for planne…
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Challenges in Analytical Method Development and Validation
Consideration should be given to the availability of required analytical and supporting equipment, software, critical reagents, standards, controls, and analysts who are skilled in the relevant analyt…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the process-qualification stage proceeds, the continuum of criticality was used to develop equipment qualification criteria and strategies for process performance qualification. Finally, in the con…
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Digitalization: The Route to Biopharma 4.0
The equipment can be interfaced with the corresponding digital twins using sensors and actuators such that the real time data is fed to the digital twins and the in silico predicted can be employed fo…
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Implementing Inline Conditioning to Advance Process Intensification
Our engineering, operations and science departments participated in the equipment design and test together with the Cytiva subject matter experts (SMEs). Our people were able to travel to Sweden for t…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
Single-use bioreactor simplification
What if a single, single-use bioreactor design could be used for both suspension and adherent cell culture? That would help dramatically simplify the equipme…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
… assays—overestimate testing needs!
Methods/equipment qualification: Methodology and equipment/reagents tested for quality control and to minimize contamination risks.
Process quali…
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Achieving Process Balance with Perfusion Bioreactors
“Since perfusion processes can run upwards of 60+ days (some even 120+ days), all of the equipment and consumables must be fully reliable, because the biocontainer cannot be changed partway through th…
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Ensuring Sterility in Small-Scale Production
In some instances, the manufacturing equipment used in small-scale batch production is portable, so this program should also encompass the introduction of the necessary manufacturing equipment into th…
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Automating Processes in Upstream Processing
BioPharm: What specific challenges do companies face when automating upstream processes?
Marshall: New product introductions into existing facilities often require new equipment process capabiliti…