Search results for " Quality attributes"

Article Quality by design for biotechnology products—part 3
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…

Article QbD and PAT in Upstream and Downstream Processing
UPSTREAM PROCESSING BioPharm: In implementing QbD, what would you identify as the critical quality attributes (CQAs) in a typical upstream bioprocess using cell-culture? Vanden Boom (Hospi…

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. …

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 Tools for Enabling Process Analytical Technology Applications in Biotechnology
The analyzers may be used for monitoring of the critical quality attributes (CQAs) of the product, performance attributes of the process, and key characteristics of the various raw and in-process mate…

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…

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