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Subvisible Particle Analysis

In recent years, regulatory expectations for more sophisticated product characteristics of biotherapeutic drugs have been extended to extend subvisible particle testing beyond pharmacopeia limits. Creative Biolabs has accumulated enough experience in particle characterization, coupled with a thorough understanding of subvisible particle characteristics and stability profiles, to provide strong support for researchers or manufacturers in product quality control.

Introduction of Subvisible Particles

Over the past few decades, therapeutic proteins have become powerful alternatives to several diseases. These proteins usually exhibit a concentration-dependent self-association tendency, which usually results in aggregates of varying sizes from nano (oligomers) to micron (subvisible and visible particles). This aggregation not only reduces the therapeutic effect but also causes adverse immunogenicity. Therefore, the measurement and characterization of subvisible particles are of great importance to the quality and safety of biotherapeutic drugs.

Currently, the US pharmacopeia and the European pharmacopeia require that biopharmaceutical products quantify subvisible particles larger than 10 μm and 25 μm, respectively. Most recently, regulatory expectations for particle characterization are being extended to particles <10 µm and even <1 µm. In the past decade, the evaluation of subvisible particles in therapeutic protein products has been focused on pharmaceutical companies and regulators, and a lot of research work has been published. Combining traditional analytical techniques to develop new analytical methods can help manufacturers of biological products cope with stricter particle regulations.

Illustrate of visible and subvisible protein particle. Fig.1 Illustrate of visible and subvisible protein particle. (Freund, 2015)

The Subvisible Particle Analysis in Creative Biolabs

The Subvisible Particle Analysis - Creative Biolabs

With the continuous improvement of technology, regulators are demanding higher and higher levels and properties of biological agents. According to the characteristics of detection methods and therapeutic protein products, each instrument has its own limitations. It is necessary to fully understand these products in order to generate high-quality data. Therefore, in addition to the pharmacopeia test of particles, a variety of orthogonal analysis methods are needed for accurate subvisible particle analysis. Creative Biolabs has rich experience in particle detection and in-depth particle data analysis, providing a wide range of detection techniques for subvisible particle characterization orthogonal technology, including but not limited to:


Our particle characterization core team can help select appropriate orthogonal particles for combination, so as to accurately quantify, characterize and identify particles in specific therapeutic protein products according to customer needs.

At Creative Biolabs, we have established a comprehensive particle characterization core service to provide analysis and characterization for subvisible particles. We have a wealth of experience in all existing methods to help customers determine which combination of technologies best characterizes each product, and provide integrated data editing across the 0.1-100 μm size range as required. If you have any requirements in subvisible particle analysis, please contact us.

Reference

  1. Freund, E.; Cao, S. Visible and Subvisible Protein Particle Inspection Within a QbD-Based Strategy//Quality by Design for Biopharmaceutical Drug Product Development. Springer. New York, NY, 2015: 331-352.

All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.

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