Formulations for clinical trials and beyond
Budget is often scarce for pharmaceutical development projects before the drug has even shown proof of concept in first clinical trials. In that early stage, many drug developing companies are hesitant to spend the money for a fully-fledged pharmaceutical development of the formulation. Thus, quite often formulations in preclinical studies and clinical stages I and […]
ProJect Pharmaceutics introduces Predictive Formulation Analytics for a rational design of optimized biopharmaceutical formulations.
Munich/Martinsried, December, 2011 Protein drug formulation is particularly challenging due to structural complexity and instability. The biological activity of most recombinant proteins emanates specifically from their 3-dimensional structure which needs to remain unaltered throughout the shelf-life of the product. However, cleavage or aggregation incidents may not only reduce efficacy but also produce adverse immunologic effects. […]