A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles

Subcutaneous (Sub-Q) drug delivery offers a convenient alternative to intravenous (IV) administration, allowing patients to self-administer medication and reducing the need for frequent hospital visits. This significantly improves the patient experience. However, delivering high drug doses via Sub-Q injection presents challenges that require innovative solutions.

Using Nanoform BIO patented platform, a highly concentrated Sub-Q formulation of an IgG1 (used as model compound) has been developed as a non-aqueous suspension. The impact of mAb particle size on the behavior of the drug product has been studied.

The study assessed the formulation's viscosity, injection force, and syringeability, along with the protein quality and activity. Researchers also evaluated the stability of both the dry particles and the resulting suspension. In vivo pharmacokinetic assessments are currently underway.

Key Learning Objectives:

• Understanding the benefits and challenges of the Sub-Q route for monoclonal antibodies (mAbs).
• Learning about Nanoform's patented process for manufacturing dry biologic particles.
• Exploring the formulation of non-aqueous suspensions for subcutaneous administration.