Search results for " capacity"
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A Q&A with Eric Langer: CMOs Embrace New Technology
Process Development Forum speaks with Eric Langer, President and Managing Partner at BioPlan Associates, and the author of a number of biopharma studies, about the 2016 13th Annual Report and Survey…
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Innovative Therapies Require Modern Manufacturing Systems
FDA also is under pressure from Congress to expand its capacity for conducting foreign drug inspections. The House Energy & Commerce (E&C) Committee recently asked the Government Accountability Office…
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Selecting the Right Viral Clearance Technology
“These advances allow for implementation of high capacity, cost-effective virus filtration steps that easily achieve required virus reduction results,” Strauss states.
New chromatography membranes…
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Biopharma Advances Demand Specialized Expertise
Lively (PPD): Growing interest in biopharmaceutical drug development necessitates partnering between clients and contractors to increase industry capacity, breadth of capabilities, expertise, and the …
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Modular Manufacturing Platforms for Biologics
A surge capacity is necessary to rapidly scale up production in case of emergencies, and a traditional manufacturing facility may not be able to meet quickly escalating demands (4).
Modular biopro…
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Modern Manufacturing Systems Key to FDA Quality Initiative
…ased to risk-based regulation, offering less oversight of operations and products that demonstrate a capacity to ensure quality and reduce risk. She reiterated this approach at the February 2015 annu…
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SEC in the Modern Downstream Purification Process
The advantage here is that the loading capacity is not limited to a set volume of 1–5% of the total column volume. The limit is set by how many of the impurities can be bound by the “hidden” ligands i…
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Viral Clearance Challenges in Bioprocessing
The achieved single reduction factors are summed up to an overall reduction factor that describes the general virus inactivation/removal capacity of the downstream process. For instance, he notes that…
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Analyzing Proteins Using SEC, MALS, and UHPLC
SEC alone generally not recommended
Because SEC is an isocratic method, peak capacity can be an issue, according to Stephan M. Koza, principal applications chemist with Waters Corporation. “Column…
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Global Expansion Shapes Drug Oversight
…ional organizations to communicate its policies and standards more clearly and to enhance regulatory capacity in emerging countries. In a March 2014 lecture to the United Kingdom’s Medicines and Heal…