Search results for "biopharm"
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New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
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Driving Improved Access to Biosimilars
Although approved, these drugs are not “interchangeable” with name-brand biopharmaceuticals, as that term has been defined in the US. Unlike small-molecule generics, biosimilars cannot automatically b…
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Methods Accelerate Biosimilar Analysis
While nIM-MS and, more so, collision-activated IM-MS have gained traction in the past few years in their applicability for analysis of higher structures of biopharmaceutical molecules, HDX–MS has been…
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Cell-Culture Advances Test Bioreactor Performance Models
In particular, the inexpensive computing power and excellent computational talent entering the biopharma industry, combined with improvements in computational fluid dynamics (CFD) and metabolic modeli…
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Monitoring and Control of Inline Dilution Processes
Challener
Process intensification is a major focus of the biopharma industry, with most efforts targeting upstream cell culture and associated processes. Buffer management has received les…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
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Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
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Jefferson Institute for Bioprocessing Opens Near Philadelphia, PA
…al Institute for Bioprocessing Research and Training (NIBRT), a center for training and research in biopharmaceutical manufacturing based in Ireland. JIB will use the Cytiva FlexFactory Platform to p…