Search results for " Quality attributes"
Article
Good Manufacturing Practices: Challenges with Compliance
When a company can design processes that consistently meet all product quality attributes, then this not only meets the base expectations provided in the GMP regulations, it is actively pursuing excel…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Figure 1: Changes of critical quality attributes, such as high-order structure, amino acid modifications, glycosylation, and stability might impact binding activity and concentration. All figures are …
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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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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Optimizing Late-Stage and Commercial Cell-Culture Processes
It is also a challenge to respond to evolving concerns on product quality attributes as new knowledge is gained.
Finally, raw material variability, including trace metal impurities in defined m…
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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…
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QbD Improves Cell-Culture Process Control
In addition, this use of PAT would allow for on-line prediction of the critical quality attributes (CQAs) required to maintain product quality and offer the ability for real-time product quality contr…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA notes that the product has unique quality attributes that can directly impact final product safety and potency, and that several manufacturing failures occurred at Novartis facilities in the Unite…
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Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability.
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…