Search results for "analytical" in Articles / App Notes
Article
Challenges in Analytical Method Development and Validation
Analytical testing can provide the data needed to produce a safe and effective drug product. The development and validation of analytical methods is crucial in drug development. While the biopharmaceu…
Article
Establishing Acceptance Criteria for Analytical Methods
Little, PhD
To control the consistency and quality of pharmaceutical products, analytical methods must be developed to measure critical quality attributes (CQAs) of drug substance/drug product. An…
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Tackling Analytical Method Development for ADCs
Their composition--a biologic linked to a small-molecule cytotoxic, which enables targeted delivery--also creates challenges for analytical method development, both for characterization and lot releas…
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An Analytical Approach to Biosimilar Drug Development
Having an analytical strategy to compare the physicochemical properties of a biosimilar to its reference product can therefore provide important clinical data to indicate that clinical similarity exis…
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Design of Experiments for Analytical Method Development and Validation
Recently, more attention has been placed on applying DOE to analytical methods. DOE for analytical methods has three major applications: method development for new methods or those that need improveme…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
… Transcript
BioPharm International: Welcome to the BioPharm International expert interview on analytical considerations for successful upstream process development. This interview, conducted in…
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The Lifecycle Change of Process Validation and Analytical Testing
…r, of Innopharma Labs in Dublin, about the impact FDA's 2011 process validation guidance has had on analytical testing and validation.
CONTINUOUS PROCESS VERIFICATION
Bio…
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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?
Let’s straighten out what really helps you achieve high-resolution analytical SEC data.
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Article
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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