Search results for " quality"
Article
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…
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Ensuring the Biological Integrity of Raw Materials
And there should be a quality assurance system in place with a system for delineation of specific batches. The supplier should have a regular audit routine. (2)
It is impractical to test all raw m…
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Biosimilars to Drive Modern Manufacturing Approaches
OBP Director Steve Kozlowski explained at the Biosimilars Council conference that extensive structural and functional characterization that identifies critical quality attributes, plus adequate clinic…
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Real Time Continuous Microbiological Monitoring
Traditional microbial monitoring within an EM program does not provide an exact quantity and quality of the microorganisms present in the manufacturing area. Numerous studies have shown that there is …