Search results for " knowledge" in Articles / App Notes
Article
DoE Provides Benefits, but Preparation Is Necessary
“With such knowledge, a scientist can make sound scientific judgments and consider the potential impact of new factors or excipients when designing a DoE study.”
LaBrenz adds that developing the p…
Article
Application of Quality by Design to Viral Safety
This is accomplished through a formal risk analysis that draws on accumulated knowledge about each step, including in-house process development data and publicly available information, such as a datab…
Article
Challenges in Analytical Method Development and Validation
In part, cultural and ‘ways of working’ differences can be overcome through training and short-term secondment, so that analysts in the ‘receiving’ laboratory acquire as much knowledge of the methodol…
Article
Gowning Practices Provide Clues to cGMP Compliance
Either finding will enable proceeding from a basis of knowledge and moving forward with confidence and a clear goal for maintaining compliance.
Reference
1. FDA, “Facts About Current Good Manufa…
Article
Raw Material Variability
At a recent BioPhorum Operations Group meeting, 17 companies pooled their knowledge and committed to a joint program of supply-chain improvement. Taken to its logical end point, the change envisaged i…
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
In the joint pilot program, which began in March 2011, FDA and EMA agreed to share knowledge, ensure consistent adherence to international guidelines related to QbD and promote the availability of pha…
Article
Outsourcing Trends in Biopharmaceutical Manufacturing
It’s true that these regions have yet to provide the institutional knowledge, facilities, and quality systems to compete in terms of commercial cGMP manufacturing infrastructure, and they have yet to …
Article
Predicting Progress in Protein Aggregation
Predicting protein aggregation
This knowledge about the relationship between the structural characteristics of peptide segments and the likelihood of aggregate formation has been used to develop …
Article
Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
Article
FDA Seeks Metrics to Define Drug Quality
Firms generally consider metrics for contractors similar to those applied internally, but also weigh supply-chain security, sterility assurance, and product and process knowledge.
Boosting capacit…