Expertise in multivariate experimental design (DOE) and our pre-designed iFormulate™ plates in combination with high-throughput technologies such as label-free nano Differential Scanning Flourimetry (nano DSF) gives us a competitive advantage compared to traditional formulation development. We can thus determine and predict protein stability and provide the right formulation rapidly and at a reduced cost.
By a rational formulation design and accelerated studies, we will identify 2-3 lead formulations, using the minimum amount of active drug substance. We will work with our client to make sure the final drug product, lyophilized or liquid is stable and in accordance with the FDA requirements. We help our clients with writing documents required for IND filing. The client will own all the results, the product, and the potential patent.
