Search results for "analytics"
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
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Tackling Analytical Method Development for ADCs
She adds that additional analytics are often used to underpin the accuracy of these methods in early development stages. LC-MS, for example, is often used to assign structural information to the indiv…
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An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
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Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
We also discuss scale up for processes where analytics intergrate with automation teams with the communications and networking teams. Balancing critical process parameters against competing requiremen…
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The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
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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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Analytical SEC: How Does Back Pressure Relate to Resolution?
High resolution in HPLC is not achieved by applying back pressure to the column. Let’s straighten out what really helps you achieve high-resolution analytical SEC data.
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Using Modeling to Improve Data Analytics for Upstream Bioprocessing Workflows
Recent trends in data analytics highlight the use of modeling techniques to improve process control and monitoring in biopharmaceutical production.
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