Search results for " facility"
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Is Your Single-Use Facility Designed with the End in Mind?
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Up-front design considerations can improve your long-term processing flexibility and ability to expand.
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Faster, Smaller, Cheaper: Optimize Your Bioprocess Facility
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Bioprocess intensification lets you maximize productivity while minimizing one or more key variables of your current biomanufacturing process, such as time, volume, or…
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Modular Manufacturing Platforms for Biologics
… all of the cleanroom components live (inside the actual unit that is shipped or inside the existing facility infrastructure). There are modular room enclosure systems (such as from Daldrop, AES, or …
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Pharma Investments Reflect Key Industry Trends
In addition, domestic manufacturers are already serving these markets, which further reduces the required facility size,” Jagschies notes. In the biosimilar sector, the stiff competition will also kee…
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Regulatory Challenges in the QbD Paradigm
…h through the review of submitted data in applications and performance of prelicense and preapproval facility inspections.
Subsequent, postapproval changes do not need the submission of supplemen…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
There are a few different strategies for overcoming these challenges, with key components including facility design, equipment selection, operational considerations, and the use of appropriate plant m…
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Continuous Manufacturing: A Changing Processing Paradigm
A traditional manufacturing facility is estimated to cost $150 million to construct, while a continuous plant would cost significantly less, analyst Marcus Ehrhardt from PwC told The Wall Street Journ…
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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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Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…
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Managing Biomanufacturing Capacity Expectations
…can lead to miscalculations of capacity, making it challenging to know what capacity to build into a facility. According to a new survey by BioPlan Associates, more than half of respondents (60%) exp…