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The biopharmaceutical shift within the drug development industry has focused increasing attention on the behavior of biological molecules in formulation. Aggregation of proteins is key to formulation and stability assessments, with a recent interest in the 100nm - 1µm aggregate size range, identified as an area of concern for immunogenicity and therefore product safety.

While the Zetasizer uses Dynamic Light Scattering (DLS) to detect the polydispersity (size spread) of biopharmaceutical formulations, Viscotek SEC products are able to separate particles present in samples by size and enable the quantity of oligomerization to be measured.

Archimedes uses the technique of resonant mass measurement to both reliably count the number of particles in the size range 50nm to 5µm (with a lower limit of detection of 200nm diameter for protein particles specifically), and also to provide measurements such as particle mass and size, and information on sample concentration, viscosity, density and volume. Via its measurement of relative buoyant mass, Archimedes is also able to distinguish between positively buoyant particles such as contaminating silicone oil, and negatively buoyant particles such as protein aggregates.

Malvern NanoSight products, using Nanoparticle Tracking Analysis (NTA) also provide an accurate, reproducible analysis and visualization of particles such as protein aggregates in formulation, in the size range 50nm to 2000nm diameter. Enabling the fluorescence mode in NanoSight instruments allows specific analysis of labeled or intrinsically fluorescent particles.

Measurement of these parameters can provide valuable information on the suitability of a product formulation and may also give an indication of the stability and prospective shelf-life of a product.

Depending on your requirements and/or position on the development pipeline, Malvern has an instrument that is able to provide a suitable level of information on issues around protein aggregation, thus ensuring your product achieves the desired stability and efficacy.

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Zetasizer Nano ZS Performance, simplicity, versatility. Image
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Zetasizer µV Modular size and molecular weight detector that can be added to any SEC system. Image
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Zetasizer APS The highest accuracy automated protein size measurement Image
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Applying complementary particle techniques for assessing comparability and biosimilarity of therapeutic products Webinar - Recorded (English)

Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, ...

Product:
Archimedes,Zetasizer range,Viscotek SEC-MALS,Morphologi G3-ID,NanoSight range
Date recorded:
September 20 2016
Language:
English


The role of Taylor Dispersion Analysis in assessing the stability of biological formulations Webinar - Recorded (English)

Understanding the stability of biological formulations – including their propensity to aggregate - is one of the primary requirements of moving drug candidates through the development pipeline. Biopharmaceutical companies will often establish a targe...

Product:
Viscosizer TD
Date recorded:
July 26 2016
Language:
English


Silicone oil-induced protein aggregation and immunogenicity Webinar - Recorded (English)

Prefilled syringes are often used for packaging and delivery of therapeutic proteins. But the silicone oil lubricant can cause protein aggregation and promote adverse immunogenicity. In this presentation, data on these two topics will be summarized. ...

Product:
Archimedes
Date recorded:
May 31 2016
Language:
English


Evaluating aggregation behavior of liposome-protein complexes using NTA Whitepaper (English)

Aggregation of both biological and synthetic materials is a serious cause for concern, posing problems at various stages of the discovery and formulation processes. Liposomes have been used in drug discovery and drug delivery for some time, and the b...



Using Taylor Dispersion Analysis to determine oligomeric state of insulin Article (English)

Taylor dispersion analysis is an emerging biophysical characterization technique that offers unique benefits in the early stages of biopharmaceutical development – providing answers that established techniques cannot effectively handle.


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