Search results for "GMP"
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Securing the Single-Use Supply Chain
…ReadyToProcess with Cytiva, which is that their use is analogous to outsourcing crucial elements of GMP operations, such as presterilization. “The role of the supplier is therefore now more critical,…
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Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
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FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…
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Explore ÄKTA pilot 600 in 3D
See how ÄKTA pilot™ 600 supports scale-up from process development to GMP clinical scale.
Explore this ÄKTA™ system in 3D
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Announcing ÄKTA ready™ extended single-use system
ÄKTA ready™ extended system is a single-use liquid chromatography system designed for process scale-up and GMP manufacturing.
The system uses disposable flow paths and prepacked …
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Innovative Chromatography Resins Can Improve Purity and Quality
The underlying affinity ligand molecule plays a critical role in the performance required for clinical and commercial GMP [good manufacturing practice] manufacturing,” he adds.
Schub notes that ex…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
BioPlan studies have shown that few processes are scaled-up, particularly for commercial good manufacturing practice (GMP) manufacture, using perfusion in continuous upstream bioprocessing CP USP. Per…
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Science Focus Fuels Successful Process Development for Startups
“We built a GMP facility to manufacture the products entirely in-house, so process development was a fundamental activity for us,” she adds.
In-house or outsource?
The decision to build its ow…
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The Challenge of Disruptive Technologies in Bioprocessing
Customers are demanding overall efficient, cost-effective solutions, faster, just-in-time service and delivery, supply chain logistics, full [good manufacturing practice] GMP documentation, high consi…
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Process Development: What May Lie Ahead in 2018?
Surely, this strategy will remain viable in 2018 and onward as firms strive to remain one step ahead in process development and prepare for later-stage GMP work.
Scientific Advancements
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