Search results for " equipment"
Article
Nurturing Knowledge from Disparate Data Streams
Regulatory considerations have also now become intrinsically linked to the traceability, security, and non-corruptibility of scientific data, again resulting in difficulties with older equipment, he n…
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A Look into the Future of Biopharmaceutical Quality
By the time updates are made to the pharmacopeias to capture the current technological advancements, more sophisticated equipment and methodologies are being introduced.
The industry seems to b…
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Process Economic Simulation for Scalable Production of Adenovirus
Process configurations using single-use equipment wherever possible were also shown to be more cost-effective than corresponding configurations using primarily stainless-steel equipment.
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Challenges in Cell Harvesting Prompt Enhancements
…entrifuge feed rate, G-force, bowl geometry, operating pressures, discharge frequency, and ancillary equipment used in the transfer of cell-culture fluid to the centrifuge. Cell-culture process chara…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Q: How are equipment and materials suppliers meeting the demand for emerging drug therapies?
A: FDA’s approval in 2017 of cell- and gene-therapies created a great deal of excitement in the industr…
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FDA Framework Spurs Advanced Therapies
…turing by Big Pharma and contract service providers, as well as within other support industries from equipment manufacturers to logistics companies.
FDA Commissioner Scott Gottl…
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Platform Technologies Improve Protein Expression
…ging from the choice of cell line, expression plasmid design, cultivation medium, growth conditions, equipment, scalability, stability, and matching purification capability, to name but a few. Primar…
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Evaluating E&L Studies for Single-Use Systems
Due to the complexity of the equipment and the single-use and multi-use materials involved, the extraction study was carried out by bracketing the different skids separately, according to the worst-ca…
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Single-Use Extractables and Leachables: Cytiva's Alignment with the BPOG Protocol
For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting stru…
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Improving Process-Scale Chromatography
In the immediate future, downstream bioprocessing will likely involve hybrid solutions with both single-use and stainless-steel equipment and limited linkage of unit operations.
While there are no…