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 II are far from being rationally designed. Particularly when it comes to therapeutic proteins, where formulation development is highly challenging due to the structural complexity and instability of the compound, pharmaceutical quality issues are the likely consequence.
Once proof of concept has been established with the rudimentary formulation, pharmaceutical companies are reluctant to change this formulation due to concerns of jeopardizing the data obtained so far in preclinical and early clinical testing.
As a result, formulations reflecting an early preclinical development status often find their way into pharmaceutical dossiers, and authorities frequently deny approval of numerous drug applications due to the lack of pharmaceutically sound data documenting state-of-the-art formulation and process development.
The key to overcome this dilemma is Predictive Formulation Analytics offered by ProJect Pharmaceutics: Plying state-of-the-art analytical methods permits us to characterize the protein molecule and analyze its response to certain excipients with regard to its intra and intermolecular physicochemical properties. This allows us to quickly and reliably identify those combinations of pH value, ionic strength, ion types, detergents and other stabilizing agents, which preserve the active 3 dimensional structure of the protein in an ideal manner.
Costs, timelines and the amount of API required for this highly efficient approach towards a rational and reliable formulation for clinics and beyond is surprisingly low.
Our deliverable will be a science-based formulation for a freeze dried product of your drug, and a conventional lyophilization cycle, ready for tech transfer to GMP manufacturing.
Once your drug has mastered critical milestones in early clinical development, call on us to carefully work out the final formulation of your drug, by means of an in-depth experimental program, to verify or optimize the quantitative composition of the drug product tailored to the route of application, the delivery system and the pharmaceutical manufacturing process.