Search results for " Quality attributes"

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 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 Determining Criticality, Part Two: DoE and Data-Driven Criticality
In Part I of this series, the author introduced the concept of continuum of criticality and applied it to the concepts of critical quality attributes (CQAs) and critical process parameters (CPPs). In …

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 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 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 Understanding Validation and Technical Transfer, Part I
…a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes” (5). In 2000, ICH Q7A defined validation as, “A documented program that…

Article Ensuring the Quality of Biologicals
has established general monographs that cover common quality attributes and that are applicable to a specific class of biologicals such as monoclonal antibodies (mAbs), rDNA products, or vaccines for …

Article Best Practices for Selecting a Top-Quality Cell Line
Defining high-quality cell lines A high-quality cell line will demonstrate high stability, scalability, and high titer, so that it can provide reproducible results—with all product quality attribu…

Article Moving PAT from Concept to Reality
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors needed for the measurement of ­critical product quality attributes and product-related species are not commercial…

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