Search results for " information" in Articles / App Notes
Article
Biosimilars: Making the Switch Comes with Challenges
…ncourage reporting of adverse effects, communications with patients groups, and wide availability of information. One important message to patients is that the variability between the reference produ…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Industry metrics will be part of a comprehensive information system that will manage the “inventory” of CDER-regulated manufacturing sites and products. This information technology system is being dev…
Article
Quality by Design and Extractable and Leachable Testing
The packaging must clearly identify its contents and may include dosage information and hazard warnings. Finally, a package may help to ensure accurate dosage of a drug product, in an easy and foolpro…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
Size exclusion chromatography (SEC) is generally used as a non-denaturing method that provides information on the apparent molecular weight, the presence of aggregates or higher molecular weight (MW) …
Article
Elucidating Biosimilars Characterization
Other methods for studying higher order protein structure such as calorimetric methods, analytical ultracentrifugation, circular dichroism, and fluorescence are capable of providing information regard…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
…timization, and then performing a long series of univariate characterization studies to complete the information required for a submission. In contrast to this approach, a second product with a diffe…
Article
The Lifecycle Change of Process Validation and Analytical Testing
Validation is the prediction of outcomes that cannot be fully observed, based on information we can observe. The more that [we] can observe, the more accurate the prediction.
In-line monitoring…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
It is expected that the annual progress reports, which will follow in 2014 and 2016, will include more detailed information on specific accomplishments related to regulatory science.
F…
Article
Optimizing your Cell Culture Process to Improve Productivity
You can use the information to extend cell viability and increase productivity—extending the cell viability by using feeds and timings can lead to increased productivity of the cells. Additionally, it…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
The International Council for Harmonization (ICH) Q6B guideline (1) provides general information on setting and justifying release and in-process specifications for both process and product-related im…