Search results for "analytical"
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
But in some cases, powerful analytical tools such as mass spectrometry, can be employed to deconvolute the results of PK studies conducted with heterogeneous source materials. To study the effects of …
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
The characterization of proteins involves identification of their complex chemical and physical structures and requires the use of a range of analytical techniques. Size exclusion chromatography (SEC)…
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Quality by Design—Bridging the Gap between Concept and Implementation
Tainsh and Pugh cited, as an example of innovation, liquid dispensing with process analytical technologies (PAT), such as near infrared (NIR) inspection, ultraviolet (UV) solution analysis, droplet we…
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Biopharma Outsourcing Activities Update
Most commonly outsourced activities
Results from BioPlan’s 2014 study’s preliminary data indicate that—as with the past two years—the most commonly outsourced activity is analytical testing of b…
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Manufacturers Struggle with Breakthrough Drug Development
Because manufacturers will have less experience with lots and manufacturing process, the need for comparability data with suitable analytical methods may increase, pointed out consultant Emily Shacter…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
For process validation Stage 1 process characterization studies, analytical methods for measuring CQAs may not yet be fully validated, but still, must be scientifically sound.
The level of accur…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
Comparability of the reference products of one original manufacturer but from different jurisdictions could be established by similarity of quality based on stringent analytical and biological assays,…
Article
Regulatory Challenges in the QbD Paradigm
Risk assessment and management, raw material management, use of statistical approaches and process analytical technology (PAT) provide a foundation to these activities.
There are many significa…
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The Future of Biopharma
The more than 100 trends identified were categorized as follows:
• 24% downstream process improvements
• 22% single-use implementation and improvements
• 24% analytical methods
• 30% o…
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Evaluating the Use of Continuous Chromatography
Advances in process analytical technologies and modeling techniques, however, may provide solutions to improving chromatography control for industrial-scale manufacturing (3). These advances offer opp…