Search results for " capacity" in Articles / App Notes
Article
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…
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Biopharma Outsourcing Activities Update
BioPlan Associates,11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, Preliminary data (Rockville, Md., April 2014).
About the Author
Eric Langer is pres…
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Brazil Emerges as Global Biopharm Collaborator
The government is establishing key partnerships with local and multinational, private, and public companies, and is funding local production capacity expansions for public and private companies. Brazi…
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A Closer Look at Affinity Ligands
Using traditional resins with small pore size leads to low binding capacity because of very low diffusion rates into the pores of the resin. LV particles are also exceptionally sensitive to pH, salt c…