Most biotherapeutic products in development are monoclonal antibodies or related formats such as bi-specific antibodies or antibody fragments. The therapeutic doses of such products across a broad range of clinically important indications are often high. In addition, it is highly desirable from a patient convenience, compliance and overall healthcare cost perspective for the resultant products to be delivered via a low volume subcutaneous injection. A combination of the high therapeutic dose and the highly desirable low injection volume often leads to a need for very highly concentrated formulations of the active ingredient. It is well known that achieving stable aqueous formulations of biotherpeutics at high concentration can be exceptionally challenging, often leading to a considerable increase in the rate of aggregation, particle formation and in viscosity. High viscosity is unacceptable as it significantly limits the injectability of the product. The Arestat™ technology consists of a series of formulation platforms that have been specifically designed to overcome the challenges associated with delivering stable aqueous formulations of high concentration proteins particularly:
- Aggregation control
- Viscosity reduction
- Improved chemical instability
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