Search results for " critical quality attribute"
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
Ensuring the Quality of Biologicals
This informational chapter, which is intended to be published by the end of 2015, has undergone public enquiry and gives examples of the critical quality attributes specific to each class of raw mater…
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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…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
…orms, moving the industry beyond simply increased titer to greater control and modulation of product critical quality attributes.
“There is also a renewed interest in non-mammalian cell-based …
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
This process helps in identifying the critical quality attributes (CQA) and is a joint effort between the client and the CMO.
CQA. CQAs are defined through execution of a risk assessment, which ev…
Article
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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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
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Eliminating Residual Impurities Starts with a Strategic Plan
Eliminating Residual Impurities Starts with a Strategic Plan
Identifying the source, assessing the risk, and removing residual impurities requires a strategic approach.
By Cynthia A. Ch…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
For example, it can be challenging to score and rank meaningfully the critical quality attributes (CQA) when developing a control strategy. Most often, there is not much patient data from the clinical…
Article
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…