Search results for " Quality By Design"

Article Quality by design for biotechnology products—part 1
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space. Design space is generally considered to be the areas where the product or process parameters can be run safel…

Article Quality by design for biotechnology products—part 3
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article Quality by design for biotechnology products—part 2
…erence on Harmonization (ICH) Q8(R2), Q9, and Q10 guidelines provide the foundation for implementing Quality by Design (QbD). Applying those concepts to the manufacture of biotech products, however, …

Article Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015 By Thomas A. Little, PhD BioPharm International Volume 28, Issue 7, pg 40–44 Approaches to the generation of process models, optimization techniques, and application of …

Article Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development. Sep 1, 2014 By: Thomas A. Little, PhD BioPharm International Volume 27, Issue 9, pp. 46-49 A product’s or proc…

Article Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems. By Jerold M. Martin Single-use technologies (SUT) have made significant inroads in …

Article Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design. Sep 1, 2014 By: Susan Haigney BioPharm International Volu…

Article Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product. Feb 01, 2015 By Anthony Grilli BioPharm…

Article Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance. Oct 1, 2014 BioPharm International …

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