Search results for " biopharmaceuticals"
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Storage of biopharmaceuticals in the frozen state has distinctive advantages. It minimizes the risk of microbial growth, increases product stability with extended shelf life, eliminates agitation and …
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Once this risk was known, it became urgent for the sake of patient safety to change the requirements for any materials used for manufacturing biopharmaceuticals to minimize the risks of transmitting d…
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Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.
By Cynthia A. Challener
Effective microbiological testing during biopharmace…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In addition to meeting the regulatory requirements that ensure the safety and efficacy of biopharmaceuticals for clinical and commercial applications, the strategy presented here also provides an appr…
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Tools for Continuous Bioprocessing Development
A key difference is that biopharmaceuticals are manufactured using living organisms, which have yet to be fully characterized, designed, and produced with precision genetic modifications. Therefore, t…
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Fluid Handling in Biopharma Facilities
…lications engineer at AdvantaPure, to get insight on the challenges and trends in fluid handling for biopharmaceuticals.
Fluid Handling Capabilities
BioPharm: What is the best way to determine …
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2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement.
In a recent survey of current trends and practices in biopharmaceutical manufacturing…
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QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) brings together different stakeholders in the ecosystem (biopharma manufacturers, suppliers, academics, government ag…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
JIB will use the Cytiva FlexFactory Platform to produce biopharmaceuticals.
According to the press release, JIB offers a range of training programs to advance the skills and knowledge of scientist…