Upcoming Live Webinars

Measuring the Opalescence of mAb Solutions with Microscale Nephelometry

Join us for a webinar on Tuesday, April 11th at 9:30 AM PDT | 12:30 PM EDT

The visual opacity of protein solutions, known as opalescence, is a phenomenon arising from molecular self-association. As a member of a group of concentration-dependent “colloidal properties”, also including high viscosity and aggregation, opalescence poses several challenges for the development of biologic drugs, particularly those intended for the high concentration formulations that are implicit in patient-centric products. Of significant concern is the relationship to the critical opalescence that accompanies phase separation.

Given the dependency of opalescence on factors such as concentration, pH, ionic strength, and temperature, it is important to incorporate measurement during the development of formulations and manufacturing unit operations in order to avoid conditions that induce phase separation. Moreover, such measurements are a valuable addition to developability screening workflows, helping to ensure that well-behaved lead candidate molecules are selected. The commercially available turbidimeters that are standard for measuring opalescence pose challenges for screening workflows because they generally require mL-scale quantities of sample.

As an alternative, we have evaluated the use of the 90° SLS channel of a microcuvette-based dynamic & static light scattering detector to enable ultra-low volume (<10 μL) opalescence measurements. These microscale nephelometric measurements afford stable performance across a broad dynamic range that covers a span of nephelometric turbidity unit (NTU) values relevant for mAb solutions. Such measurements are in good agreement with those made using a commercial turbidimeter, but with the low sample consumption required for screening paradigms. Turbidity measurements made with such an instrument are also suitable for small molecule formulations and other pharmaceutical development and QC applications.


Determination of Critical Product Parameters for NanoDDS

Join us for a webinar on Wednesday, April 19 from 10:00 CEST

Across development, production and quality control of nanoparticle based drug delivery systems (nanoDDS) it is essential to monitor critical product parameters. Attributes such as payload, size and titer need to be assessed to ensure product efficacy and safety. Light-scattering based analytical techniques are robust tools, that allow reliable determination of these attributes. In this webinar we will review which quality attributes of nanoDDS can be measured with light-scattering. The benefits of each technique will be discussed by presenting selected nanoDDS application examples.


AF4-MALS Method to Characterize Production and Functionalization of Outer Membrane Vesicles for Conjugate Vaccines

Join us for a webinar on Tuesday, April 25 from 10:00 CEST

With the ongoing development of conjugate vaccines battling infectious diseases, there is a need for novel carriers. Outer-membrane vesicles (OMVs) are an excellent alternative to traditional carrier proteins. In addition to their size, OMVs have self-adjuvanting properties and are therefore ideal as a vaccine component or antigen carrier. An essential and important aspect of their development for vaccine products is characterization of OMVs with respect to size and purity. In this seminar we will discuss the development of an Asymmetric Flow Field Flow Fractionation - Multi Angle Light Scattering (AF4-MALS) method for OMVs, which was recently published in Analytical Chemistry. NIST-traceable particle-size standards and BSA as a model protein were used to verify the precision of the size and purity analysis of the OMVs. The validation program according to the principles provided in the ICH Guidelines Q2 (R1) to assess the quality attributes of the results obtained by AF4-MALS analysis is shown.


Recent Webinars

Previous webinars may be viewed in our Webinar Library. The following recent webinars are now available:

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