Search results for " GMPs" in Articles / App Notes
Article
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
Cost and speed are critical components in biomanufacturing. See how ÄKTA pilot™ 600 supports scale-up from process development to GMP clinical scale.
Explore this ÄKTA™ system in…
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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
By: Feliza Mirasol
Recent innovations in chromatography resins offer promising advantages in downstream bioprocessing.
With ongoing efforts to increase monoclonal antibody (mAb) productivi…
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options. …
Article
Science Focus Fuels Successful Process Development for Startups
Getting the science right helps biopharma startups overcome development and commercialization challenges.
By Cynthia A. Challener
sdecoret/Stock.Adobe.com
Pr…
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The Challenge of Disruptive Technologies in Bioprocessing
The Challenge of Disruptive Technologies in BioprocessingIncreasing demand for biologics is driving the need for innovation in bioprocessing.
Jul 01, 2018
Increasing demand for biologics is drivin…
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Process Development: What May Lie Ahead in 2018?
2018 is shaping up to be an interesting year in the world of biopharmaceuticals. What have 2017 developments taught us, and what may lie ahead for biopharmaceutical drug developers and process engin…
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Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…