The effects of excipients on the viscosities of protein formulations are examined in a new application note published by Malvern Instruments.
Low-volume viscometry for the study was performed with the recently launched Viscosizer 200, a benchtop system which performs automated viscosity measurements on very low sample volumes over a wide range of concentrations.
This, it is claimed, makes the instrument particularly useful in early stage biopharmaceutical development.
The work was conducted at Malvern by applications engineer Dr Oksana Leszczyszyn, who specialises in the analytical characterisation of proteins.
The company says it demonstrates the utility of the Viscosizer 200 in discerning differences resulting from different formulations and shows how the system can be used as a tool in screening for appropriate formulation candidates.
“As biotherapeutics are usually delivered by injection at relatively high concentrations, formulation viscosity is critically important, and a variety of small molecule excipients may be used to reduce viscosity by inhibiting protein aggregation,” said Dr Leszczyszyn.
“Having the ability to screen formulations for viscosity issues or against a particular viscosity threshold at an early stage of development when sample volumes are limited, using a system such as the Viscosizer 200, will facilitate and expedite candidate selection and contribute to quicker, more cost-effective routes to market,” Leszczyszyn added.
The Viscosizer 200 is the latest product to reach commercialisation as a result of Malvern Instruments’ Bioscience Development Initiative.
Designed primarily to help solve key analytical challenges at the preformulation stage of pharmaceutical, and particularly biopharmaceutical, development, the automated Viscosizer 200 delivers viscosity and molecular size data on UV-active samples, using volumes of less than 10 µL.
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