Search results for "manufacturing"
Article
Process Chromatography: Continuous Optimization
Yield drives cost of goods (COG), so not having an affinity purification solution can greatly impact the COG for biotherapeutic manufacturing,” Terova explains.
With the increase in more challengi…
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Reconciling Sensor Communication Gaps
…ciling information obtained at bench- or process-development scale with what may be expected during manufacturing. “The setup is different, the sensors are different,” explains McNeel. “There’s a def…
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Platform Approach Speeds Process Development
For manufacturing of biopharmaceuticals, the generation of stable transfected production cells is the standard procedure due to higher batch-to-batch consistency and yields. Stable cell lines are typi…
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CMOs Concerned With Cost of Single-Use Equipment
By Eric Langer
Contract manufacturing organizations (CMOs) have been enthusiastic adopters of single-use technologies in recent years, lauding their range of benefits and attributing significant i…
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Host-Cell Protein Measurement and Control
The HCP composition and abundance are unique to their respective host and the manufacturing process used for biologics production. Meanwhile, different host cells and manufacturing processes may produ…
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A Bright Future for the Plasma Fractionation Industry
… treated to a full program with six scientific sessions focusing on issues and possibilities around manufacturing, development, and clinical use of plasma products in general. In addition, a poster s…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Aggregation risk factors
Certain manufacturing stages influence the risk of chemical degradation, which increases the risk of physical degradation and the formation of aggregates. “These stages in…
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Trends in Single-use Bioreactors
Another example of how single-use systems can facilitate continuous processing is the ease with which a single-use bioreactor that has been operated in a fed-batch manufacturing process can be readily…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Tingley (Repligen): Yes, the single-use chromatography products we are discussing were launched for clinical-scale manufacturing within the past two years. They are designed to improve downstream proc…
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Using Quality by Design to Develop Robust Chromatographic Methods
… Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop robust manufacturing processes for pharmaceutical products and substances. The aim of these documents is t…