Search results for "manufacturing" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
Relationship Building at Top of Mind for Clients
12-14
Contract manufacturing organizations (CMOs) should have the technical expertise to be considered by clients for partnerships. As results from BioPlan Associates’ 11th Annual Report and Survey…
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
PDF: Contract Manufacturing Organizations (CMO’s) seem to be assuming a larger role in biopharma processing. Can you tell us why that is?
Eric: Based on our 11th Annual Report, this focus on pro…
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Q&A with Industry Leaders: Rita Peters
This trend continued at Interphex 2014 with the introduction of equipment and systems targeting biologics manufacturing.
In other developments, mergers, acquisitions, and supplier consolidation co…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Additionally, these models have been confirmed, by experiment or prior knowledge, to adequately represent the full-scale manufacturing process. This classical multivariate approach combines impact fro…
Article
Best Practices in Adopting Single-Use Systems
Potential adopters must focus on which criteria to consider as their plant’s manufacturing capacity evolves away from multi-use unit operations to disposable components and systems.
Bioproce…