Search results for " design"
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion (specification limits) is crucial in design space generation and use. Design space is proposed by the applicant and is subject to regulatory assess…
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
…
Article
Evaluating Design Margin, Edge of Failure and Process
46-49
A product’s or process’ design space is generally considered to be the area where process parameters safely (without failure or high amounts of degradation) can be processed and achieve al…
Article
Quality by design for biotechnology products—part 1
…armonization (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, involves so…
Article
Challenges and Trends in Biopharma Facility Design
26-30
Facility design is an important aspect of biopharmaceutical manufacturing. “Global deployment, cost pressure, time to market, and change/uncertainty” are some of the factors biopharma comp…
Article
Design and Qualification of Single-Use Systems
With increasing regulatory oversight of SUT processes, it’s worthwhile to review basic concepts of design and qualification that apply to single-use components and systems (SUS).
Equipment Design …
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
But when building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?
Facility design i…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
Article
Application of Quality by Design to Viral Safety
Identification of a multivariate design space in which data support the impact that multidimensional process parameter ranges will have on critical quality parameters enables process consistency. The …
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…