There are a significant number of complex investigational biotherapeutic products in development such as monoclonal and bi-specific antibodies, fusion proteins and antibody fragments which cross a broad range of clinically important indications. These products often require a high therapeutic dose and low volume subcutaneous injection delivery is preferred for patient convenience, compliance and reduction of overall healthcare costs. This leads to a need for very highly concentrated formulations of the therapeutic protein. Achieving stable aqueous formulations of therapeutics at high concentration can be exceptionally challenging, often leading to a considerable increase in the rate of aggregation, particle formation and high viscosity which significantly limits the injectability of the product.
What Arecor can do
Our Arestat™ technology offers a series of formulation options that have been specifically designed to overcome challenges associated with delivering stable aqueous formulations of high concentration proteins. In particular, the technology, addresses:
- Aggregation control
- Viscosity reduction
- Improved chemical instability