Search results for " quality"
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The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
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New Therapies Present Scaling Challenges
…an be used to support the increased manufacture of allogenic cell therapies, provided that a product quality profile for the allogenic cell therapy has been established and is well understood (2, 3).…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
Common to each, however, would be design criteria to minimize risk in manufacturing, including unidirectional flow of personnel and materials in the cleanrooms, proximity to a quality control lab for …
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An Analytical Approach to Biosimilar Drug Development
That is due to the natural variability and inherent complexity in manufacturing of biologics for which the demonstration of identical quality attributes (pharmaceutical equivalence) as required by the…
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Achieving Process Balance with Perfusion Bioreactors
single use
Long process durations, high oxygen transfer rates, and short mixing times are not a challenge for quality stainless-steel bioreactors equipped with double mechanical seals or magnetic …
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Using Multiple Techniques in Biosimilar Analysis
Standard testing routines comprise a selection of experimental techniques chosen because of their ability to monitor various quality attributes of the molecule. These are typically among those listed …
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Establishment of New Modern Plasma Fractionation Facilities in Asia
…ities, all of which utilize modern chromatographic processes to produce plasma products of very high quality and safety. It is not inconceivable that over the next decade China will become a major pl…
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Making the Move to Continuous Chromatography
… chromatography can also give additional process robustness and control and lead to improved product quality levels, which can be particularly useful when processing unstable molecules.
Access…
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What's in Your SOP?
SOPs document the steps of key processes to help ensure a consistent, quality output. SOPs are useful tools for operationalizing, optimizing, and communicating important corporate policies, government…
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Transformative Medicines Challenge FDA and Manufacturers
At a conference in October 2017 on oligonucleotide-based therapeutics sponsored by FDA and the Drug Information Association (DIA), experts explored strategies for tackling quality risk management, set…