Search results for " attribute" in Articles / App Notes
Article
Improving Upstream Predictability
At the contract development and manufacturing organization Lonza, at-line and on-line sensors have improved control of critical quality attributes, says Mohindra. The company is using in-line sensors …
Article
Risk Assessment: Studying Chromatography Resin Variability
This article focuses on process robustness and the impact of chromatography resin attributes as well as how to identify which parameters and interactions to focus on in your process characterization s…
Article
Monitoring and Control of Inline Dilution Processes
Monitoring and control
When looking at the buffer preparation process, the target product profile should be defined first followed by critical quality attributes and critical process par…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
And then, finally, a digital solution encompassing electronic batch records, process monitoring, scheduling, and other key process attributes should be designed-in early to add efficiency and control …
Article
Emerging Therapies Test Existing Bioanalytical Methods
This leaves investigators asking questions about how to demonstrate the key bioanalytical attributes specified in the guidance, namely demonstrating that the method measures the intended analyte, eval…
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
Article
Webinar On Demand: Expanding SPR Uses in Antibody Effector Function Determination
Critical quality attributes (CQAs) are fundamental to regulatory compliance. CQAs typically include data on how the candidate interacts with target proteins, as well as process-related CQAs such as pr…
Article
Are You in Control of the Quality of Your mAbs?
Better biotherapeutic characterization for improved quality control
At the recent WCBP conference in Washington, D.C., Dr. Stuart Knowling from Antibody Analytics presented how the latest innovati…
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
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Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
This could be attributed to differences in expression system, culture conditions, purification processes, formulations, or storage conditions of the product and need to be suitably addressed as per th…