There are a broad range of biotherapeutic products both on the market and within development that are delivered via intravenous infusion. Whilst therapeutically effective, this route of delivery presents a number of challenges. It requires a lengthy infusion to be delivered by a health care professional in a medical setting, which is inconvenient for the patient as well as placing a significant cost burden onto the respective healthcare system. It is highly desirable both from a patient quality of life and compliance perspective as well as reduction of cost burden to enable subcutaneous delivery of these biotherapeutics. In many cases, it has simply not been feasible to overcome the considerable product formulation challenges to enable a stable aqueous product that can be delivered via subcutaneous injection as opposed to intravenous injection. For example, if a pre-filled syringe is the intended delivery device then the volume of the subcutaneous dose is limited to 1-2 mL, ideally 1 mL. Therefore, the active ingredient needs to be formulated at a significantly higher concentration for subcutaneous delivery compared with intravenous infusion. This often results in unsurmountable stability challenges as well as unacceptably high viscosity when utilising conventional formulation science.
The Arestat™ technology consists of a series of formulation platforms that have been specifically designed to overcome the challenges associated with delivering product reformulations that enable a switch from intravenous infusion to subcutaneous delivery, particularly:
- Aggregation control
- Viscosity reduction
- Improved chemical instability
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