Correlating Viscosity and Particle Size Parameters determined by SAXS Studies of concentrated MAb Solutions

Monoclonal antibodies (MAb) solutions are a major class of biopharmaceuticals with various applications. However, challenges like a high viscosity at the required MAb concentrations need to be addressed at an early development stage.

MAb Solutions

Monoclonal antibodies are important biopharmaceuti-cals for treating diseases such as cancer, inflamma-tion, allergies, infectious diseases and cardiovascular diseases. The challenge is, however, the low potency of MAb and the high viscosity of concentrated MAb solutions. Injection volumes bigger than 1.5 mL are not suitable for subcutaneous administration. Due to the low potency, MAb solutions often need to be con-centrated in order to cover the required dosage at a reasonable volume. But as a consequence viscosity is a technical issue for the stability and manufacturability of MAb solutions and negatively affects the usability for subcutaneous injection.

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