Search results for "quality"
Article
QbD Improves Cell-Culture Process Control
However, using a quality-by-design (QbD) approach that employs predictive modeling can improve the quality of end product as well as the efficiency of the bioprocess.
Real-time quality control
…
Article
Unifying Continuous Biomanufacturing Operations
…dels that could eliminate scale-up altogether; test the consequences of continuous lines on product quality and stability; and consider what vendor gaps exist that could preclude a completely end-to-…
Article
Being Thorough When Transferring Technology
Other examples are unexpected low titer compared to process development runs or unexpected filter clogging in depth-filtration steps due to different quality of filtration starting material. An exampl…
Article
Global Expansion Shapes Drug Oversight
… global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere. To better assess product risks, Hamburg proposed “enhanced inte…
Article
Manufacturers Struggle with Breakthrough Drug Development
Demonstrating efficacy is not the problem, she noted; the greater challenge is to ensure quality manufacturing and access to needed diagnostics.
CMC issues
FDA grants breakthrough status f…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
In Part I of this series, the author introduced the concept of continuum of criticality and applied it to the concepts of critical quality attributes (CQAs) and critical process parameters (CPPs). In …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Furthermore, with the increasing emphasis on Quality by Design (QbD), there is a need to develop paradigms to apply QbD not only to mAbs but also to other BioTx.
Early biotechnology products in th…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
…44 - The impact of filing accelerated review applications on process development
11:41 - What quality teams should do to ensure quality standards are maintained in the absence of traditional re…
Article
Using Software in Process Validation
By Robert Glaser
Within pharmaceutical manufacturing, the goal of process validation is to build quality into the operation at every step to ensure consistent product quality. It seems straig…
Article
Design and Qualification of Single-Use Systems
…be constructed so that surfaces that contact raw materials, intermediates, or APIs do not alter the quality of the intermediates and APIs beyond the official or other established specifications” (2-4…