Search results for " information" in Articles / App Notes
Article
Raw Material Variability
Changing to a chemically defined material would be preferred but is not always possible for legacy products where the license has been submitted with detailed raw material and other bioprocess informa…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Techniques of measurement system analysis such as Gage repeatability and reproducibility (Gage R&R) studies are recommended because they provide information on the variability of the measurement syste…
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Early Communication with Regulators is Essential for SMEs
…y because of fees reductions and also because companies could make electronic submissions of product information. This year, the rate of increase has slowed down with the total registrations by late …
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Climate Change in Outsourcing
Clinical CROs morphed from temporary staffing agencies into information technology innovators as the nature of clinical research changed. Similar shifts are expected to make over the CDMO and CMO indu…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
In 2008, the FDA's Office of Biotechnology Products invited companies to participate in a pilot program involving the submission of quality information for biotechnology products in an Expanded Change…
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Reviewing the Importance of Biosimilarity and Interchangeability
Data required for regulatory evaluation
Both biosimilarity studies and interchangeability studies provide information that is crucial for regulatory authority evaluation. Stamm emphasizes that ea…
Article
Introducing the VH3 ligand ELISA kit
Learn more about the VH3 ligand ELISA kit and view detailed product information
Article
Save the date for HTPD 2025
More information and ‘Call for abstracts’ will come within soon.
Stay updated on htpdmeeting.com
Article
Top Tips for Successful Development of Antibody Chromatography Processes
Each experiment will not give you that much information, but the combination will give more learnings than running one experiment at a time.
And to really increase your learning, you can als…