Search results for " control"
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Smart Bioprocessing has been chosen as the theme to emphasize the importance of understanding and controlling the origin of impurities, the impact of the production sources considered for the process,…
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The Metrics of Quality Culture
Quality systems metrics might look at change control, investigation root-cause trends, and release-testing cycle times.
There is no set requirement on which metrics a company should track to measu…
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Cleaning of Dedicated Equipment: Why Validation is Needed
Moreover, the company failed to put in place intra-campaign controls aimed at verifying that during a production campaign the level of potential degradation residues in the equipment was maintained to…
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Breakthrough Drugs Raise Development and Production Challenges
Effective communication with contract manufacturers is crucial, as is a transparent presentation in the application of design evolution and a rationale for commercial manufacturing process and control…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
… conveyance, and retention of manufacturing knowledge to improve technology transfer, which provides controlled publication and distribution of manufacturing system standards and operational best pra…
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Vaccine Development and Production Challenges Manufacturers
Proposals seek to tighten timelines for the Centers for Disease Control and Prevention (CDC) to recommend new vaccines, for FDA to expedite vaccine exports, and for the National Institutes of Health (…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
FDA notes that changes to protein chemistry that may otherwise be well controlled in other environments “may occur in vivo in the context of the relatively high pH of the in-vivo environment or in inf…
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Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Customers have expressed that they feel they have less control over this step if an external supplier performs the packing, rather than it being done in-house. However, once customers start using prep…
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Viral Clearance Challenges in Bioprocessing
In these cases, close monitoring of the process, preferably using automated systems, and a good quality assurance/quality control program are essential for preventing such problems, according to Zhou.…