Search results for " Quality attributes"
Article
Reimagining Affordable Biosimilars
Analytical and functional evaluation of the quality attributes of a biotherapeutic product is an integral part of process development (see Figure 1). This characterization is typically followed by pre…
Article
Leveraging Data for Better Biopharmaceutical Process Control
The aims of optimization and control were present at earlier phases for PAT in biopharma, but today it is possible to monitor product quality attributes end-to-end (E2E) in upstream and downstream pro…
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Being Thorough When Transferring Technology
Therefore, the process controls that were identified and demonstrated during process validation studies to maintain consistent and reproducible manufacturing processes and product critical quality att…
Article
Platform Approach Speeds Process Development
Depending on the project objectives, product gene optimization is performed to improve expression rates and modulate particular product quality attributes or product properties.
Currently, the maj…
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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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Manufacturers Struggle with Breakthrough Drug Development
27, 2014) that breakthrough drug development requires information on critical quality attributes, potential scale-up strategies, comparability exercises, and validation plans. FDA will want to know ho…
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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
Advancing QbD in the EU
…ach to quality assurance or an "enhanced" structured approach, which involves concepts like critical quality attributes (CQA), design space, and control strategies.
The industry has been urgin…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Using Software in Process Validation
to ensure that the finished product meets all quality attributes, including specifications.
Documentation and traceability for compliance
Part of the validation process is in the documentati…