Search results for " equipment" in Articles / App Notes
Article
Efforts Accelerate to Streamline Postapproval Change Process
Change challenging
Manufacturers typically make dozens of routine changes in facilities, equipment, processes, and testing every year for every product; the vast majority are minor and managed wit…
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Modeling Bioreactor Performance
Clapp also stresses that off-the-shelf products only provide the engine for modeling; the user, equipment supplier, or third-party service provider must have the capability to create a model and perfo…
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Downstream Processing Continues to Worry CMOs
Some of the biggest gaps between these groups relate to developing processes with fewer steps and to using single-use equipment in downstream processing. Indeed, a majority of CMOs are considering usi…
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Maximize resin usage with continuous bioprocessing
PCC increases the use of available resin and enables smaller equipment footprint and shorter processing times compared with batch processing.
To learn more about continuous chromatography, and oth…
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Reporting Quality Metrics to FDA
For example, metrics will be different for a site that manufactures a large variety of products in multipurpose equipment in small numbers of batches, compared with a site that produces large volumes …
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Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
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Continuous Processing for the Production of Biopharmaceuticals
In addition to eliminating several hold steps, the advantages of this platform were realized in the form of increased process throughput and decreased equipment footprint.
Figure 2: Archi…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The absence of chemical reagents, surface modifications, or complex equipment, however, makes this technique an attractive alternative for laboratory scale cell detachment from t-flask-like culture de…
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Framing Biopharma Success in 2016
Investing in infrastructure
Attractive credit terms in recent years prompted some biopharma manufacturers to invest in facilities and equipment. Encouraging companies to make capital improvements …
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The Metrics of Quality Culture
When establishing site metrics, the company could look at inspection history including internal audit findings and maintenance history such as equipment age versus defect-failure rates. People metrics…