Search results for " facility" in Articles / App Notes
Article
FDA Seeks Metrics to Define Drug Quality
Conversely, a shorter cycle time may indicate that a facility operates in a high state of control. Process and product performance index (Ppk) values similarly can be a sign of an optimal control stra…
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Remote Monitoring and Big Data Advance Upstream Automation
Machine learning and AI capabilities are moving to the production environment, and as mobile equipment gets more advanced and cheaper, facility floor workers are being provided access to augmented rea…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
As a result, the variety of buffer solutions used across a biopharma manufacturing facility requires flexible, cost-efficient infrastructure and on-time delivery to meet process demand.
At…
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Cytiva Opens Biotechnology Manufacturing Center in UK
The facility has 3000 ft2 (280 m2) of cleanroom space and employs 20 people. The fiber-based purification products will be prepared in Stevenage before being further processed and finish…
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What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Hybrid Bioprocessing: A Q&A with Andrew Sinclair
In the therapeutic protein space, there has not been a truly SU facility at commercial scale.
What could be the main reasons and/or the main drivers that hybrid bioprocessing are being used? Is th…
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Managing Risk in Raw Material Sourcing
To identify and assess risk, the company uses a documented risk-assessment process, facility audits, and a toolkit that includes such methods as failure modes and effect analysis, fishbone diagrams, a…
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Defining Risk Assessment of Aseptic Processes
Recently, the facility has experienced an increase in the number of viable organisms in our environmental monitoring program. Management has asked me to do a risk-based assessment so we can use our re…
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Process Chromatography Selection for Downstream Processing Applications
Becerra-Arteaga (MilliporeSigma): The process developed at laboratory scale may not completely fit in the facility where the scaled-up process will be transferred. For example, the tanks available may…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
A successful response plan achieves effective area containment, allows rapid virus elimination through effective disinfection, and enables speedy facility return to the routine manufacturing regimen. …