Search results for "Start-up" in Articles / App Notes
Article
Science Focus Fuels Successful Process Development for Startups
“As a start-up develops, ensuring the supporting cast puts an emphasis on the underlying science and the ability to translate such science into a desirable product that can be manufactured consistentl…
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Automating the Biomanufacturing Process
“RTR entails higher up-front cost for the equipment and start-up/validation, but allows batches to be released much faster with less human intervention,” Lebl says.
The need for integration betwee…
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Understanding Validation and Technical Transfer, Part 2
The installed and qualified equipment may then be used in start-up and training exercises to ensure everything, including coffee shop staff, is ready for a successful opening day.
Validation of…
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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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Unifying Continuous Biomanufacturing Operations
…n clinical trials today is approximately four weeks, with approximately four-five days dedicated to start-up time. “There are more and more companies investigating five-to-six-week processes as skill…
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Tools for Continuous Bioprocessing Development
New advancements in the field of microbioreactors
Recently, a microfluidics-based bioreactor system was introduced by Pharyx—a recent start-up out of MIT—for continuous and perfusion processes (Fig…
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Fluid Handling in Biopharma Facilities
I think the cost of SUS must justify the reduction of contamination risk and reduction of facility support/utility requirements, not to mention the shortened start-up time that also includes the train…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
When single-use systems are chosen, however, he adds that they are fairly rapid to install and start-up, particularly relative to older legacy technologies, so the impact on facilities and utilities s…
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Modular Manufacturing Platforms for Biologics
In addition, closed modular systems are said to reduce required manufacturing area, HVAC requirements, chilled water and steam demands associated with cleaning, construction and start-up times, and po…
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Early Communication with Regulators is Essential for SMEs
From EMA’s viewpoint, one big success story with its new relationship with SMEs has been the way it worked closely, from an early stage, with the Dutch start-up uniQure to enable its product alipogene…