Search results for "flexible"
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Regulatory Challenges in the QbD Paradigm
The desired state was defined as "a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high quality drug products without extensive regulatory oversight." …
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Technology Innovations Improve Process Chromatography Performance
Process intensification is another viable approach through which equipment footprint could be reduced and manufacturing could be made more flexible.We also see work being done in the space of real-tim…
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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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Advanced Technologies Facilitate Scale-up and Technology Transfer
“For established facilities, modular processing units enable a quick and easy transition to the hybrid facility format, while for new facilities, they are making the fully flexible single-use facility…
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Monitoring and Control of Inline Dilution Processes
We also developed an operator control platform that is flexible and familiar to GMP [good manufacturing practice] production environments,” Gach remarks.
The company has also incorporated buffer…
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Continuous Manufacturing: A Changing Processing Paradigm
In addition to reduced inventory, lower capital costs, a smaller ecological footprint, and more flexible operation, FDA is an advocate of the fact that continuous manufacturing reduces manual handling…
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Trends in Single-use Bioreactors
…steel systems that are already in place make some users reluctant to switch to the more economical, flexible, single-use bioreactors. And although it is an increasingly less common need, single-use b…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Biopharma companies invested resources to update facilities and establish new modular, flexible line operations. Competitors formed partnerships and licensing arrangements to meet production goals at …
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Remote Monitoring and Big Data Advance Upstream Automation
Blend of advances in hardware, software, equipment, and sensors/analytics
Flexible technology deployments have in general enabled products to be scaled up or scaled out more rapidly and thus launc…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
…stomers—and, therefore, multiple known and unknown products, processes, and setups—and having a flexible floor plan are critical. We need to be able to accommodate for multiple products and different…