(43e) Chemical Engineering and Biopharmaceutics: Linking the Process with the Ultimate Quality Attribute

The discovery and development of heterocyclic, small molecule new drug entities is a highly sophisticated, multi-disciplinary, scientifically advanced, collaborative, highly competitive, extremely expensive and multi-year endeavor.  The heavily R&D dependent pharmaceutical industry utilizes cutting edge scientific and technological tools and techniques encompassing the broad disciplines of chemistry, biology and medicine. To provide significantly improved therapeutic treatments for various acute and chronic diseases and to be able to meet the requirements and expectations of the regulatory agencies, the patients and the society is a constant challenge for the innovative pharmaceutical industry.  The challenges forge deeper dives in science among the wide array of disciplines that constitute the pharmaceutical industry and consequently have provided tremendous opportunities for the advancement of computational and predictive tools within each of these disciplines and sub-disciplines.  A key segment of R&D and industrial scale manufacture is pharmaceutical sciences. It is an amalgamation of applied disciplines of chemical engineering, physical and physical organic chemistry, synthetic organic chemistry, process chemistry, analytical chemistry, polymer chemistry, material sciences, crystallization science, drug product design and manufacture and evaluation of performance of drug product in the patients.   Pharmaceutical sciences have also embraced the development and use of predictive computational tools among each of its areas of specialization and disciplines to ensure the highest quality of drug product being delivered to the patient.  The multi-disciplinary components of pharmaceutical sciences are operationally integrated to provide the highest quality of drug product to meet the regulatory requirements in this highly regulated industry.  However, there is a lack of integration of such predictive tools across disciplines to enable the assessment of local perturbations in quality during any segment of work flow on the ultimate quality and performance of the drug product.  The ultimate quality attribute of a drug product is it’s performance in patients, however, linking that performance to the upstream attributes of drug substance and drug product via engineering control during manufacture with emphasis on the principles of chemical engineering continues to be unrealized and unfulfilled possibility. The vision to provide such integrated approach of existing computational and predictive tools within disciplines and sub-disciplines in pharmaceutical sciences and to provide opportunities for further development of advanced integrated tools as a holistic system is the underlying concept for the creation of Systems Based Pharmaceutics.