Search results for " critical quality attribute"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Critical quality attribute identification/assay development: Identify and develop assays for critical quality attributes, potency assays—overestimate testing needs!
Methods/equipment qualific…
Article
A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
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
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…
Article
Best Practices for Selecting a Top-Quality Cell Line
Special attention in this case should be paid to critical quality attributes such as glycosylation, which can add a variable to clonal selection and process development and can lead to a scenario wher…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
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
Moving PAT from Concept to Reality
“Not only are there many possible downstream unit operations, but also the critical quality attribute (CQA) most impacted by each step is diverse. The traditional methods for quality attribute measure…
Article
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…