Search results for " quality" in Articles / App Notes
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
…atively slow, which has resulted in only incremental improvements in safety, efficiency, and product quality. The rise of costly biologics over the past 20 years, however, has put greater pressure on…
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Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Stay up-to-date with our new e-book on the latest in SPR technology and use in the fields of process development and product quality control.
Download the free e-book on Better Biotherapeutic Char…
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Modern Manufacturing Key to More Effective Vaccines
Similarly, Cristiana Campa of GSK Vaccines in Italy emphasized that the complexity of vaccine development makes it important to define a control strategy for identifying critical quality attributes as…
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Impurity Testing of Biologic Drug Products
“Whilst removal or inactivation of these agents is considered under the production process validation as a safety issue rather than tested in the final product as a quality concern, these agents can a…
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Roadmap Leads to Innovative Biomanufacturing Strategies
…: The biomanufacturing industry has responsibility to bring better, faster, cheaper, and higher quality therapeutics for serving patients. Biomanufacturers are uniquely aware of the challenges faced …
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N-Glycan Analysis of Biotherapeutic Proteins
The impact of glycosylation on protein function means that glycosylation can be a critical quality attribute (CQA), making the characterization of N-glycan structures an essential part of the biothera…
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Fusion Proteins Pose Manufacturability Challenges
For example, the low-pH elution step used in the initial protein Acapture step may induce large amounts of aggregation, impacting product quality and yields. “Frequently, routine cell-culture and puri…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
For example, for the commonly used ion-exchange chromatography, pH, ion concentration, gradient, and stationary phase can affect the recovery step as well as the resulting product quality.
For com…
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Single-use Bioreactors Have Reached the Big Time
Commercial choice
As such, Norris sees single-use bioreactor processes designed with the entire workflow in mind, delivering a high quality, optimal biologic titer into the downstream unit operati…
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Ensuring Sterility in Small-Scale Production
The environmental monitoring program for small-scale batch production should provide the information on the quality of the aseptic processing environment including any ancillary areas such as the equi…