Search results for "quality" in Articles / App Notes
Article
Nurturing Knowledge from Disparate Data Streams
One example relates to the move to a quality-by-design approach to process development. With this approach comes a geometric expansion in the quantity of data being acquired to characterize a process.…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Case Study I: Identification of Critical Quality Attributes of Granulocyte Colony Stimulating Factor (GCSF) (9)
GCSF is a 18.8 kDa cytokine that is generally prescribed to boost neutrophi…
Article
Managing Residual Impurities During Downstream Processing
Increased understanding of potential impurities and their consequence to the ultimate quality, safety, and efficacy of biopharmaceuticals--as well as improvements in analytical technology that provide…
Article
Modeling Bioreactor Performance
The accuracy of any simulated results is, however, directly related to the quantity and quality of the data inputs and the resolution of the model.
Why model bioreactor performance?
Ther…
Article
Vaccine Development Faces Urgency and Challenges
The extensive process was needed to document unchanged quality attributes of the adjuvant under a new automated quality control system.
Similarly, Wilson Forsyth, director of quality control at As…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… made to improve recombinant protein production to meet the demands of high quantity and consistent quality of biopharmaceutical products. Those efforts can be categorized into two fundamental areas:…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
… in accordance with existing legal and regulatory standards, guidance, and Agency policy related to quality assessment.” The ETT will assess if proposed technology will improve the quality of manufac…
Article
Viral Clearance Challenges in Bioprocessing
In these cases, close monitoring of the process, preferably using automated systems, and a good quality assurance/quality control program are essential for preventing such problems, according to Zhou.…
Article
DoE Provides Benefits, but Preparation Is Necessary
“The quantitative models for these multiple quality attributes can then be used for global optimization of the formulation, leading to more robust formulation development,” she says. Nguyen also notes…
Article
Evaluating Design Margin, Edge of Failure and Process
…s safely (without failure or high amounts of degradation) can be processed and achieve all critical quality attributes (CQAs) and associated product acceptance criteria. Knowledge of product or proce…