Search results for " quality"
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Downstream Processing for Cell-Based Therapies
As such, manufacturing processes need to be adapted to ensure that the cellular material retains its functionality and the critical quality attributes (CQAs) are maintained throughout the entire proce…
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Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
“Biosimilars are constrained in that they have to hit certain quality parameters set by the innovator,” Elhofy says. Essential Pharmaceuticals provides an animal-component free media that boosts titer…
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Evaluating E&L Studies for Single-Use Systems
Regulatory guidelines require that the product contact items “shall not be reactive, additive, or absorptive” to assure drug product quality and safety (2). The manufacturer is, therefore, responsible…
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Defining Risk Assessment of Aseptic Processes
Schniepp
Q: I work in the quality group for a manufacturer who makes intravenous (IV) injectable drugs using aseptic processing techniques. Recently, the facility has experienced an increase in the…
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Generating a Fully Processed Antibody
Producing these multisubunit molecules or processing proteins in the correct proportions to obtain maximum titer and biopharmaceutical quality can be difficult using traditional cell-line development …
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Continuous Processing for the Production of Biopharmaceuticals
The key drivers for this evolution include rising demand, the desire for reduced processing costs, more stringent requirements for consistent quality, and most importantly, the requirement for higher …
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Going Small to Achieve Success on the Commercial Scale
The impact of QbD and DoE
The quality-by-design (QbD) approach to process development requires characterization of the impacts of different process parameters on product critical quality attribute…
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Selecting a Comprehensive Bioburden Reduction Plan
and Vince Anicetti, executive director of quality, Coherus Biosciences. Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm tech…
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A Bright Future for the Plasma Fractionation Industry
Among the quality and regulatory trends, Quality-by-Design (QbD) remains to be a popular topic. Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Pro…
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Optimization of Protein Expression in Escherichia Coli
Here, the authors discuss some parameters that can influence protein yields and quality during protein expression in E. coli.
Bacterial strain selection
The choice of a bacterial strain for prot…