Search results for " information"
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The New World of Biopharmaceutical Manufacturing
Being able to provide consistent information from drug manufacturers to health authorities around the globe will ultimately favor the prompt launch of more medicines to meet the needs of many patients…
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Managing Residual Impurities During Downstream Processing
The standard provides information on the assay development cycle, development and characterization of HCP reagents, method development and qualification as fit for use, how to address dilution lineari…
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Protein Purification Questions and Answers from ÄKTA Club Web Chat
ÄKTA club is a free, online community for ÄKTA system users with easy and quick access to trustable information about ÄKTA systems and protein purification.
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HTPD: Optimizing a mAb Chromatography Polishing Step
High-throughput process development (HTPD) shortens development time while increasing the amount of information available during early process development.
In this webinar, a case study using hi…
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Ensuring Sterility in Small-Scale Production
The environmental monitoring program for small-scale batch production should provide the information on the quality of the aseptic processing environment including any ancillary areas such as the equi…
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Evaluating E&L Studies for Single-Use Systems
Based on the preliminary risk assessment and on existing information (from other extraction studies and from the supplier), some items were excluded from the small-scale assembly, simplifying the stud…
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Improving Process-Scale Chromatography
“The benefits can be even greater when data on raw production materials from different suppliers can be consolidated and used as an integral part of a business’ information management structure,” she …
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Establishing Acceptance Criteria for Analytical Methods
Methods with excessive error will directly impact product acceptance out-of-specification (OOS) rates and provide misleading information regarding product quality.
Traditional Measures of Analytic…
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Real Time Continuous Microbiological Monitoring
LIF is an ultrasensitive and rapid microbiological method for air monitoring that provides valuable process information in real time. In addition, the pharmaceutical industry has been called upon to c…
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High-Throughput Process Development Handbook
High-throughput process development (HTPD) shortens development time at the same time as it increases the amount of information available during early process development. Evaluating chromatographic c…