Search results for "analytical"
Article
Modular Manufacturing Platforms for Biologics
Jornitz notes that there has been recent interest in the use of pods for analytical, microbial, polymerase chain reaction, and assay development, as well as interest in the use of pods for broader hea…
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Modern Manufacturing Systems Key to FDA Quality Initiative
…in development or under review by the agency, including orphan drugs and biosimilars that raise new analytical challenges. OBP now has four Divisions of Biotechnology Product Review & Research, each …
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Re-use of Protein A Resin: Fouling and Economics
Users employ a variety of analytical tools to monitor Protein A resin deterioration over time. These include lysophosphatidic acid (LPA) analysis and HETP measurement, as well as monitoring of bioburd…
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Vaccine Development and Production Challenges Manufacturers
that its development program for its meningococcal serogroup B vaccine benefited from the application of “an extensive analytical toolkit.” That facilitated in-depth characterization of both process a…
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Fermentation for the Future
For soluble proteins and microbial expression, BI provides an integrated approach that combines strain development, automated upstream- and downstream-processing, and analytical assessment.
Altern…
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Technologies and Practices Must Evolve to Meet Demand
Nearly two-thirds of the 2015 respondents reported that they employ process analytical technology (PAT). More than 42% cited better process understanding and increased efficiency or reduced waste as p…
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Securing the Single-Use Supply Chain
“These results indicated that the materials were comparable within the variability of the analytical techniques used,” Briggs says. He also recognizes that tubing is a universal single-use component, …
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Trends in Single-use Bioreactors
…eil (Thermo Fisher Scientific): We have seen several advancements in single-use sensors and process analytical technologies to use with single-use bioreactors. In addition, there are improved control…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
…nterest in continuous manufacturing was pushed by QbD implementation, in particular that of Process Analytical Technology (PAT). The key PAT concepts, namely real-time product quality-based decision …
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Fourth is the extension of the QbD concepts from the traditional process development to analytical development and other key activities associated with the commercialization of biotech therapeutics.
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