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Protein Dynamics in Living Cells

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Different fluorescence-based techniques are used to study the protein dynamics in living cells. These techniques include FRAP, FRET, and PET.
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Deep Proteome Profiling by Isobaric Labeling, Extensive Liquid Chromatography, Mass Spectrometry, and Software-assisted Quantification

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Sub-visible particle quantitation in protein therapeutics.

S Cao¹, N Jiao, Y Jiang

¹Process and Product Development, Thousand Oaks, CA 91320, U.S.A. scao@amgen.com

Pharmeuropa Bio & Scientific Notes

|February 11, 2010

Summary

Quantifying sub-visible particles in biologics is crucial for patient safety. This study modifies the light obscuration method for accurate biopharmaceutical particle analysis throughout product development.

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Area of Science:

Pharmaceutical Science
Analytical Chemistry
Biotechnology

Background:

Biologics are a significant and expanding part of the pharmaceutical market.
Sub-visible particles in biologics pose potential patient safety risks and require thorough investigation.
Consistent particle control from development to commercial release is essential for therapeutic biologics.

Purpose of the Study:

To address the limitations of compendial methods for sub-visible particle quantitation in biologics.
To present modifications of the light obscuration method for biopharmaceutical applications.
To demonstrate a strategy for particle analysis across the product lifecycle.

Main Methods:

Modification of the compendial light obscuration method.
Adaptation for various protein concentrations and administration routes.
Development of optimized sample preparation and sampling plans.
Application to therapeutic protein products.

Main Results:

Demonstrated successful application of the modified light obscuration method to therapeutic protein products.
Showcased enhanced sizing information and reduced assay volumes.
Presented a viable strategy for particle analysis in biologics.

Conclusions:

The modified light obscuration method is suitable for sub-visible particle quantitation in therapeutic biologics.
A comprehensive strategy utilizing complementary methods ensures robust particle control.
Accurate particle analysis is critical for ensuring the quality and safety of biologic drugs.