Register for the first ever RheoSense hosted Protein Formulation & Characterization Forum!
This single day event is bringing together a panel of speakers from both industry and academia to share their expertise in protein characterization, including drug development, formulation, stability, and injectability. Our goal is to facilitate the discussion of protein formulation and characterization, with a focus on rheology and viscosity applications. With expert presentations and live Q&A sessions this is a MUST ATTEND for anyone working in biopharmaceutics, research and development and and other protein formulation position!
Interactions, clustering, and rheology of highly concentrated antibody solutions
William 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
Thomas 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.
The role of viscosity measurements in the design of injectable biomaterials
Abigail 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.
Download the FREE Virtual Biopharma Forum recordings using the form to the right!