Search results for " validation" in Articles / App Notes
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
He also covered the latest regulatory strategies and a new assay validation guideline for surface plasmon resonance (SPR) technology.
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Article
Validation of the production of influenza virus in ReadyToProcess WAVE™ 25 bioreactor system
This application note describes the validation of the single-use ReadyToProcess WAVE 25 rocking bioreactor system in production of influenza virus from Vero cells in microcarrier-based cultures. A 2…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
… and recovery testing of the sampling technique, and visual inspection performed during the cleaning validation. Each element of the justification needs to be reviewed and evaluated during the cleani…
Article
Assessing Manufacturing Process Robustness
In 2011, FDA’s revised process validation (PV) guidance (7) extended ICH’s concepts to the pharmaceutical product lifecycle, an approach that is now being applied to cleaning validation and other area…
Article
Reconciling Sensor Communication Gaps
…inst the well-known benefits of single-use processing, including the avoidance of cleaning, cleaning validation, and calibration.
For most of the history of the biomanufacture of therapeutic prot…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances (2-4) advocating a new paradigm of process validation based on process understanding and control of paramet…
Article
Impurity Testing of Biologic Drug Products
“Whilst removal or inactivation of these agents is considered under the production process validation as a safety issue rather than tested in the final product as a quality concern, these agents can a…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The study also includes development and validation of the platform method for quantitation of glucose as one of the key components of studied media.
Materials and methods
All eight multi-compo…
Article
Emerging Therapies Test Existing Bioanalytical Methods
Current FDA guidance provides little direction on how to approach assay development and validation when using these emerging technologies, nor is there guidance for the application of more familiar te…
Article
The Importance of Partnering for Bioanalytical Studies
FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., Eur…