Search results for " attribute"
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
Moving PAT from Concept to Reality
In many cases, Makowiecki adds, reliable, low cost, on-line/at-line analytical sensors needed for the measurement of critical product quality attributes and product-related species are not commercial…
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
Robust Optimization, Simulation, and Effective Design Space
Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, and material attributes is a primary goal of drug development. Even though there are ICH guidance doc…
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
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
Leveraging Data for Better Biopharmaceutical Process Control
Are more biomanufacturers adopting PAT and advanced control in biopharma?
Menezes:The initial use of PAT in bioprocessing was focused on monitoring specific culture attributes in upstream proce…
Article
Reimagining Affordable Biosimilars
With an anticipated valuation of over $200 billion by 2022, this popularity of protein-based biologics can be attributed to their unique target specificity in protein–protein interactions for the trea…
Article
Best Practices for Selecting a Top-Quality Cell Line
Defining high-quality cell lines
A high-quality cell line will demonstrate high stability, scalability, and high titer, so that it can provide reproducible results—with all product quality attribu…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
It is also a challenge to respond to evolving concerns on product quality attributes as new knowledge is gained.
Finally, raw material variability, including trace metal impurities in defined m…