Currently,~80% of biologics are administered intravenously due to high doses and challenges associated with high concentration protein formulation development – viscosity, stability including aggregation and volume. As a result, patients are tethered to IV infusion set-up for hours, few times a month often in a clinic or hospital, adding significant cost. Subcutaneous delivery enhances patient compliance and convenience, while significantly reducing the cost associated with hospitalization.
Only a handful of technologies have attempted to address the protein formulation challenge, that too, with several disadvantages. They work on two principles – Enzyme based technologies (for e.g. Halozyme and Alteogen) and viscosity reducing Technologies (for e.g. Bhami Research Lab (BRL), Reform Bio, Excelse Bio, Arsia Therapeutics, Arecor, etc.).
Amongst the available technologies, BRL’s high concentration platform offers one of the most effective protein formulation solution – Global IP, applicable to a wide range of proteins, formulation with concentration >250 mg/mL, viscosity in the range of 20-25 cP, use of GRAS category excipients with no safety concerns.
It is timely for pharma companies to not only consider high concentration protein formulation technologies not only for pipeline molecules, but also, conversion of IV to SC for marketed products, as a lifecycle management strategy.
Our in-depth understanding of the biobetters space and relevant tech platforms allow us to identify and evaluate appropriate protein formulation technologies relevant to your pipeline. We would be happy to schedule an introductory call to discuss further on protein formulation/biobetter strategy