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Specific decrease in solution viscosity of antibodies by arginine for therapeutic formulations.

Naoto Inoue¹, Eisuke Takai, Tsutomu Arakawa

¹Faculty of Pure and Applied Sciences, University of Tsukuba , 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8573, Japan.

Molecular Pharmaceutics

|April 3, 2014

Summary

High viscosity in antibody formulations can be reduced using arginine hydrochloride (ArgHCl). This excipient effectively lowers solution viscosity for subcutaneous injections, even at high protein concentrations.

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Laboratory Scale Production and Purification of a Therapeutic Antibody

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Published on: January 24, 2017

Area of Science:

Biopharmaceutical formulation
Protein chemistry
Drug delivery

Background:

High protein concentration formulations often exhibit high viscosity, posing challenges for subcutaneous administration.
Therapeutic antibody doses and volume restrictions necessitate concentrated formulations.

Purpose of the Study:

To investigate the effect of arginine hydrochloride (ArgHCl) on the viscosity of high-concentration antibody formulations.
To determine if ArgHCl can reduce viscosity to acceptable levels for subcutaneous injection.

Main Methods:

Viscosity measurements of bovine gamma globulin (BGG) and human gamma globulin (HGG) solutions at high concentrations (250 mg/mL and 292 mg/mL, respectively).
Evaluation of ArgHCl's impact on viscosity across different pH conditions.
Comparative analysis of ArgHCl's effect on antibody solutions versus other globular protein solutions (α-amylase, α-chymotrypsin).

Main Results:

ArgHCl significantly decreased the viscosity of high-concentration BGG and HGG solutions to below 50 cP.
The viscosity-reducing effect of ArgHCl was observed at physiological, acidic, and alkaline pH.
ArgHCl specifically reduced the viscosity of antibody solutions, but not other globular proteins, suggesting specific interactions.

Conclusions:

Arginine hydrochloride is a potent excipient for decreasing the solution viscosity of high-concentration antibody formulations.
ArgHCl facilitates the development of concentrated antibody formulations suitable for subcutaneous administration.
Specific interactions between ArgHCl and antibodies are indicated by the selective viscosity reduction.