Search results for "CQA"
Article
A Closer Look at Affinity Ligands
Leached protein A is considered a CQA (critical quality attribute) to measure for with a release specification that must be met before the product can be released.Much progress has been made in recent…
Article
What is process development?
Those activities must be combined with the right analytics, so you can accurately measure what you’ve identified as your product’s critical quality attributes (CQAs) as you develop and refine your pro…
Webcast
A route to deeper process understanding-Studying resin variability using a Process Characterization
Chromatography resin attributes can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
Ligand density is an important…
Article
On-Demand Webinar: A Route to Deeper Process Understanding—Studying Resin Variability Using a Process Characterization Kit
Chromatography resin attributes, such as ligand density, can affect critical quality attributes (CQAs) as well as process performance depending on the process design and the separation at hand.
…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
…h quality attributes are the most critical to track, or whether further critical quality attribute (CQA) assays need to be appended to the quality control systems. This is where exhaustive product ch…
Article
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…
Article
Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Process Development: What May Lie Ahead in 2018?
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Bioburden Control in the Biopharmaceutical Industry
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Impact of Media Components on CQAs of Monoclonal Antibodies
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Start with the End in Mind GMP Tech Transfer
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A…
Article
Being Thorough When Transferring Technology
…intain consistent and reproducible manufacturing processes and product critical quality attributes (CQAs) within pre-defined limits need to be maintained during the technology transfer to the recipie…
Article
Going Small to Achieve Success on the Commercial Scale
…acterization of the impacts of different process parameters on product critical quality attributes (CQAs), which in turn necessitates considerable experimentation, according to Meizinger. “While the …