Biomolecule Analytics
Hear from PPD experts at our cGMP labs.
Biomolecule analysis is a complex and lengthy process. It starts with early candidate characterization and is followed by extensive analytical support for active pharmaceutical ingredient and formulation development. It also includes analytical support for scale-up and product comparability, release, stability and quality control studies. Below, our cGMP team shares its firsthand experience with some critical aspects of biomolecule analytics.
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Steve Becht, Ph.D., senior research scientist, cGMP labs, talks about immunogenicity concerns and how these issues drive biomolecule characterization during drug development.
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What are the major differences between biomolecules and small molecules?
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What information does advanced mass spectrometry offer that traditional methodology doesn’t?
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Why is it important to have the high level of detail provided by mass spectrometry?
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When should information be obtained via mass spectrometry?
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What role does characterization play in developing a viable formulation and manufacturing process?
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Bob White, Ph.D., group leader, cGMP labs, discusses cell-based assays and their unique applications and requirements in relation to biomolecules.
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Why are cell-based assays important to protein drug discovery, development and characterization?
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What are the reasons for inclusion of cell-based assays in biopharmaceutical product characterization and testing?
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How do cell-based assays support the goals of product safety and efficacy?
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What are the regulatory requirements regarding cell-based assays?
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Jeff Staecker, Ph.D., laboratory manager, cGMP labs, talks about the underlying principles and factors that affect biomolecule method development and validation.
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Can you define analytical method validation?
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What is the process for analytical method development and validation?
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What are the guiding principles governing the selection of analytical methodologies?
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What are your thoughts on how to navigate through this complex analytical process?
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The above experts provide an overview of the needs for orthogonal testing in biomolecule characterization and testing.
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Why should one use orthogonal testing for biomolecule analysis?
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Could you give an example of orthogonal testing?
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How is the test menu selected for orthogonal testing?
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How can orthogonal testing address a clinical issue?
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What is PPD’s experience with orthogonal testing?
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