Search results for "CQA"
Article
Assessing Manufacturing Process Robustness
Stage 1, process design assessment, involves the following steps:
determining the quality target product profile and justification of critical quality attributes (CQAs) and critical…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Target/ligand binding is an essential critical quality attribute (CQA) that needs to be monitored. The enzyme-linked immunosorbent assay (ELISA) is often used to assess ligand binding; however, it is …
Article
Essentials in Quality Risk Management
Quality risk management (QRM), as defined in International Conference on Harmonization's (ICH) Q9 document (1), is designed to ensure that drug critical quality attributes (CQAs) are defined and maint…
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Quality by design for biotechnology products—part 1
Pharmaceutical product sponsors begin by identifying product requirements to meet patient needs and then determine the quality target product profile (QTPP) and the critical quality attributes (CQAs) …
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Application of Quality by Design to Viral Safety
A QbD approach to drug development starts with the definition of critical quality attributes (CQA) that the final drug product will possess, and then outlines the development path to achieve these goa…
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Quality by Design and Extractable and Leachable Testing
QTPP information informs the second element of QbD, the critical quality attributes (CQA).
CQA is defined as a physical, biological, or microbiological property or characteristic that should be …
Article
Essentials in Establishing and Using Design Space
…afely (without failure or high amounts of degradation) and achieve all critical quality attributes (CQAs), product and process acceptance criteria, and specifications. Knowledge of product or process…
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Addressing the Complex Nature of Downstream Processing with QbD
QbD incorporates the identification of critical quality attributes (CQAs) through a quality target product profile (QTPP). Critical material attributes (CMAs) and critical process parameters (CPPs) ar…
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Understanding Validation and Technical Transfer, Part 3
It is one part of the overall product control strategy and forms the basis for the critical quality standards (CQAs) that will be approved by regulatory authorities. The product specification is estab…
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Leveraging Data for Better Biopharmaceutical Process Control
As data management becomes more sophisticated, the possibility of retrieving and aggregating data from critical process parameters (CPPs) and critical quality attributes (CQAs) in real-time will allow…