Search results for "Biomanufacturing"
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Automation Trend in Fill/Finish Reduces Contamination Risk
In May 2017, the company completed an expansion of its aseptic fill/finish operations at its GMP biomanufacturing facility in Rockville, MD, where it installed a new, fully automated vial-filling syst…
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Leveraging Data for Better Biopharmaceutical Process Control
We have developed a soft sensor applications for GMP biomanufacturing in which media components quality attributes are related to upstream yields or bulk product CQAs (e.g., stability) (4,5).
B…
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Making the Move to Continuous Chromatography
“Multicolumn chromatography has long been an accepted continuous purification practice by small-molecule manufacturers, but is just now gaining traction in the biomanufacturing space,” he says.
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What's in Your SOP?
What’s in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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Platform Technologies Improve Protein Expression
Ventria is in the process of doubling our production capacity with the platform to meet growing needs in developing new biotherapeutics, cell-culture media reagents for biomanufacturing, and industria…
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Will My Buffers Work When Using an Inline Conditioning System?
Compared with traditional buffer preparation, in-line conditioning can help increase efficiency in buffer production for biomanufacturing applications.
Will my specific buffers work? This is on…
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Single-use Bioreactors Have Reached the Big Time
Automation and process control, both of which are essential to enabling consistent and reliable biomanufacturing, have improved greatly for single-use bioreactors as well. “Historically, single-use te…
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Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
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Biopharma Advances Demand Specialized Expertise
Also, the increasing trend toward outsourcing of GMP biologics manufacturing ensures bioprocessing and testing is performed by expert manufacturers with proven track records in quality and biomanufact…
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Relationship Building at Top of Mind for Clients
Figure 1: Selected outsourcing issues: biomanufacturing by CMOs.
This consideration has been moving up the rankings over the years. Of the 19 factors assessed, it was the fourth-most important back…