Search results for " quality"
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
“Proper training for operators on proper procedures and immersing them in the quality mindset is foundational,” he insists. “Investment in employee satisfaction and career development can help keep tu…
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
Balancing critical process parameters against competing requirements for critical quality attribute (CQA) specifications. We also touch upon continuous versus batch manufacturing.
Topics…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
With the changing industry tide favoring multiproduct manufacturing facilities, methods to enhance efficiency without sacrificing quality or safety are needed,” he says.
Several activities must be…
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Raw material quality control (QC) testing can also be reduced or eliminated by implementing single-use technologies, saving time from reduced process steps as well as labor costs.
The increa…
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Mapping a Route for Cell and Gene Therapy Process Development
The additional steps aim to increase the quality of the product, but may also reduce the quantity,” he observes.
Similar process development challenges
Early processes developed for cell ther…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Due to its bioprocess-associated variability and impact on safety, pharmacokinetics, and pharmacodynamics, glycosylation is widely regarded as a critical quality attribute (CQA) of TGPs (1).
In th…
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Nurturing Knowledge from Disparate Data Streams
One example relates to the move to a quality-by-design approach to process development. With this approach comes a geometric expansion in the quantity of data being acquired to characterize a process.…
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Preclinical Evaluation of Product Related Impurities and Variants
Case Study I: Identification of Critical Quality Attributes of Granulocyte Colony Stimulating Factor (GCSF) (9)
GCSF is a 18.8 kDa cytokine that is generally prescribed to boost neutrophi…
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Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…
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Modeling Bioreactor Performance
The accuracy of any simulated results is, however, directly related to the quantity and quality of the data inputs and the resolution of the model.
Why model bioreactor performance?
Ther…