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Biopharma Forum 2022

FREE SESSION RECORDINGS! 

2022 Protein Formulation & Characterization Forum

Revolutionizing protein characterization together!

The Power of Viscosity

RheoSense hosted Protein Formulation & Characterization Forum Session Recordings.

This single day event brought together a noteworthy panel of speakers to share their expertise in protein characterization, including drug development, formulation, stability, and injectability. The expert presentations and Q&A session recordings are a MUST DOWNLOAD for anyone working in biopharmaceutics, research and development and and other protein formulation position!


Session Recordings

Interactions, clustering, and rheology of highly concentrated antibody solutions
Kimball_Headshot_2022William Kimball, McKetta Department of Chemical Engineering, University of Texas at Austin Graduate Research Assistant
Highly concentrated therapeutic antibody solutions are desired for subcutaneous delivery, but exhibit prohibitively high viscosities. Here, we discuss the effect of pH and additional cosolutes on the viscosity of antibody solutions, and characterize the underlying interactions and clustering that determine viscosity using small angle x-ray scattering (SAXS), coarse-grained molecular dynamics simulations, and shear rheology.

 

Impact of Viscosity on the Manufacturability of Paired Monoclonal Antibodies
Tom McNerneyThomas McNerney, Sound Biologics 
Sound Biologics has developed several full-length monoclonal antibodies (mAb) cGMP manufacturing process where both mAbs are produced in a single Chinese hamster ovary (CHO) cell. The paired mAbs are purified and formulated and are currently in or have successfully completed early phase clinical studies.  We have observed that mAb-mAb interactions with itself or paired with another mAb can produced a highly viscosity solution, which challenged the development of a process to fit within an existing GMP manufacturing facility. Besides the usually suspects that impact protein solution viscosity (such as amino acid sequence, mAb concentration, and solution composition) to modulate viscosity, we have observed the propensity of the mAb to form a gel as the temperature decreases correlated to higher viscosity for single mAb’s and paired mAbs solutions. This gelling propensity is similar in behavior to published work on proteins commonly used in the food industry. Our data showing the various factors mention above, increased or decreased the unpaired or paired mAb’s solution viscosity is presented here.

Viscosity as an Indicator of Small molecule drug binding with DNAs
Stacey Elliott, PhD, Principal Scientist, RheoSense 
Chrystian Ochoa, PhD, Application Scientist, RheoSense
Sohelia Shabaniverki, PhD, Application Scientist, RheoSense
DNA is often the cellular target for binding studies with certain classes of small molecule drugs. The extent of disruption to the DNA confirmation will vary with the different binding modes. Since viscosity is sensitive to the molecular level structure, the presence of bound drug molecules can increase the viscosity of DNA in solution to varying extents depending on the binding modes present. We demonstrate the use of viscosity measurements to characterize the binding of the drug sumatriptan to calf thymus DNA in Tris-HCl buffer. Viscosity data is presented for solutions prepared with a fixed concentration of DNA and varying levels of sumatriptan. The rate of increase in viscosity with the drug to DNA ratio and its relevance to the dominant drug binding mode is also discussed.
 

The role of viscosity measurements in the design of injectable biomaterials
abby grosskopf-1Abigail K. Grosskopf, PhD, Genentech
Hydrogels combine the stress-bearing ability of a solid with the permeability and flow characteristics of a liquid. They occur naturally in cells and tissues, and have been synthesized for a wide variety of applications. Understanding the microscopic origins of their mechanical properties is thus important for both directing engineering and deciphering biological designs. We apply bulk oscillatory rheology to hydrogels comprised entirely of rationally designed DNA 'nanostar' cross-links, leveraging the unique designability and equilibrium bonding of DNA to study the effect of junction valence and bond strength heterogeneity on network mechanics and structure.

 

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