Search results for " Quality attributes"

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
… Q8/Q9/Q10 (2-4), many companies are challenged by the evolving concept of criticality as applied to quality attributes and process parameters. Historically, in biopharmaceutical development, critica…

Article Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Biotech therapeutics, particularly complex products such as monoclonal antibodies (mAbs), can have numerous quality attributes that can potentially impact safety and/or efficacy of the product (2). Id…

Article Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
  In Part I, the author used risk analysis and applied the continuum of criticality to quality attributes during the process design stage of process validation. After using process kno…

Article Critical Quality Attributes Challenge Biologics Development
By Susan Haigney Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…

Article Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
As Jose Menezes, CEO of 4Tune Engineering, pointed out in a white paper (1), biologics can have a million times more critical quality attributes (CQAs) than small molecules, and many more of them are …

Article Quality by design for biotechnology products—part 1
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 Bioterminology: A Guide to the Biopharmaceutical Lexicon
The development process should identify and describe the critical quality attributes and critical process parameters that influence product quality and performance.  pharmacodynamics Study of the …

Article Regulatory Challenges in the QbD Paradigm
Under this paradigm, manufacturers have extensive knowledge about product, process, and quality attributes and strive for continuous improvement to reach the desired end point of consistent, safe and …

Article The Metrics of Quality Culture
Critical quality attributes. The third quality-culture optional metrics involves trying to use critical quality attributes (CQA) as a key indicator of a quality culture. Of the three optional metrics …

Article Quality by design for biotechnology products—part 2
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…

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