Search results for " QbD"
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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Faster Flavivirus Vaccine Production
Viral vaccines need to be produced fast and in large quantities. Routine immunizations and preventive campaigns, like stockpiling in response to emergencies, involve millions of doses, and speed is es…
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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…
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The Value of Digital in Biopharma
To be successful in making targeted therapies, biopharma manufacturing must evolve into smaller, faster, and more efficient environments. Digital technology and data science can be leveraged to add …
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
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What’s New in Upstream Technologies
Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
By Amber Lowry
SCIENCE PHOTO - STOCK.A…
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Case Study: Virus Reduction of an Affinity Capture Step
Evaluating how much a process step contributes to viral clearance is an essential part of process validation. For this reason, there is an industry need to perform effective viral clearance studies. I…
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…