Search results for " design"
Article
QbD and PAT in Upstream and Downstream Processing
However, with current bioreactor engineering controls, these parameters may be tightly and confidently controlled within the design space of the manufacturing process permitting these parameters to be…
Article
PDA's Technical Report for Biotech Cleaning Validation
LeBlanc
ABSTRACT
Quality by Design principles such as design space can also be applied to cleaning validation. As discussed in the recently published PDA Technical Report No. 49: Points to Consi…
Article
DoE Provides Benefits, but Preparation Is Necessary
28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist to examine the formulation design space in a statistically significant manner from the beginning of ex…
Article
Breakthrough Drugs Raise Development and Production Challenges
Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are meeting deadlines and goals for assessing breakthrough designa…
Article
Flexible Facilities for Viral Vector Manufacturing
It’s critical to have a facility design that is flexible enough to adapt to product pipeline diversity,” says Joe Makowiecki, Enterprise Solutions director of business development at Cytiva.
Modul…
Article
Addressing the Complex Nature of Downstream Processing with QbD
The International Council for Harmonization (ICH) defines QbD as a systematic approach that incorporates prior knowledge, results of studies using design of experiments (DoE), use of quality risk mana…
Article
Evaluating E&L Studies for Single-Use Systems
Finally, the definition of the study design is a very important and crucial step. Different extraction study design options are available for the manufacturing process contact materials:
• P…
Article
Understanding Validation and Technical Transfer, Part 3
Cell modification processes should be developed based on studies designed to show the effectiveness of those processes. Equipment, operating procedures, and processing conditions should be selected on…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Product safety and quality by design (QbD)
Traditionally, product safety has relied on the incorporation of three key measures into the manufacturing process: selection, testing, and viral clearan…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabilities have changed the face of bioprocess design. First, the availability of high-throughput miniature bioreactors has made …