Search results for " activity"
Article
Trends in Single-use Bioreactors
Both setups allow for cell-free media extraction and permit continued cellular activity inside the vessel.
Galliher (Cytiva): Yes. Because single-use bioreactors are much simpler than stainless …
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Optimizing Resin Performance with Disposable Chromatography Solutions
Although the initial uptake of single-use chromatography solutions has been relatively slow, an increased need for higher-capacity resins and the demand for smaller batches has made disposable chrom…
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High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Is QbD activity company-wide or occurring within smaller groups in the company?
QbD implementation started off as something that smaller groups would get involved with. However, as these concepts h…
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Continued Process Verification for Biopharma Manufacturing
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Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
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Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
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Analyzing Proteins Using SEC, MALS, and UHPLC
In addition, Pothecary says that characterization of oligomers, which are ordered assemblies of multiple proteins, is important because oligomerization controls protein activity. Measurement of molecu…
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.
A lack of single-use technologies
The greatest barrier for adoption …
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Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…