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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions
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Protein particulate detection issues in biotherapeutics development--current status.

Tapan K Das1

  • 1Pfizer Biotherapeutics Pharmaceutical Sciences, 700 Chesterfield Parkway West, Chesterfield, Missouri 63017, USA. tapan.k.das@pfizer.com

AAPS Pharmscitech
|May 9, 2012
PubMed
Summary

Particulate formation in biotherapeutics is a quality concern. Emerging technologies offer better characterization of these protein aggregates and particles across a wider size range.

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Area of Science:

  • Biopharmaceutical Science
  • Analytical Chemistry
  • Materials Science

Background:

  • Particulate and aggregate formation in biotherapeutics is a significant quality concern.
  • Large aggregate quantities can elicit immunogenic responses.
  • Comprehensive characterization of diverse protein particulates remains challenging.

Purpose of the Study:

  • To provide an overview of emerging technologies for particulate characterization in biotherapeutics.
  • To discuss the advantages and limitations of these newer methods.
  • To highlight their application in understanding particulate formation mechanisms.

Main Methods:

  • Review of recent advancements in particulate detection technologies.
  • Analysis of techniques covering submicron to micron size ranges.
  • Comparison of emerging methods with traditional assays like HPLC and visual inspection.

Main Results:

  • Significant increase in the development of novel detection technologies.
  • Emerging technologies provide complementary data across a wider size spectrum.
  • These advancements aid in understanding particulate formation mechanisms.

Conclusions:

  • Newer analytical techniques are crucial for comprehensive particulate characterization.
  • Addressing submicron and low-micron particulates is key to understanding formation.
  • These technologies enhance quality control and safety in biotherapeutics development.