Search results for " production" in Articles / App Notes
Article
Evaluating the Use of Continuous Chromatography
In addition, continuous processing intensifies production and lowers capital costs, while enabling better control (1).
Although significant strides have been made to advance continuous upstream pr…
Article
Improving Upstream Predictability
Currently, he says, 50–60% of biopharmaceutical developers and manufacturers have either implemented or are considering use of perfusion for seed train or production bioreactor steps. Used with high c…
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Science Focus Fuels Successful Process Development for Startups
For BriaCell’s CEO, Bill Williams, there are three aspects to process development: process development in the production of its novel therapeutics (both drug substance and drug products), in the desig…
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FDA Framework Spurs Advanced Therapies
As importantly, she notes that FDA must be aware that some of the well-established manufacturing and quality systems used to support the production of well-established medicinal products may not alway…
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QbD Improves Cell-Culture Process Control
Mammalian cells are most frequently used as the hosts for manufacturing complex biopharmaceuticals, and cultivation of these host cells is a key factor in the production of biotherapeutics. The cultiv…
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Contract Manufacturing Through the Years
… had large internal laboratories and manufacturing facilities for process development and commercial production. There wasn’t a biologics contract manufacturing sector, and early entrants such as Amg…
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Defining Risk Assessment of Aseptic Processes
…dard operating procedures (SOPs), and monitoring deviations for breaches in aseptic technique during production. The concepts set forth in the FDA guideline are also set forth in the European regulat…
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Selecting the Right Viral Clearance Technology
…the implications if all goes well and the molecule advances to late-stage development and commercial production,” agrees Strauss.
For well-understood steps, such as detergent or low pH inactivati…
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CMOs Continue to Improve Overall Biomanufacturing Performance
Results from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) offer some clues as to what CMOs are doing to remain competitive.
CMOs…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
FDA’s focus on the need for updates is creating both opportunities and challenges for biologics manufacturers involved in the scale-up and transfer of production technologies. Single-use and modular t…