(548f) Implementing a Flexible Recipe Management Strategy for Development of Biopharmaceuticals

Optimizing the process of developing novel biopharmaceutical products is an area of great promise to deliver value to patients and clinicians.  A key fundamental prospect in optimizing that process is defining flexible standards through which we communicate our processes and associated data.  The S88/S95 recipe data standards have proven a great mechanism to provide that framework in the chemical industry and applying them to Biopharmaceuticals is challenging.  The challenge lies in the diverse number of systems and processes that must adopt the recipe structure including API production and Drug Product manufacturing, technology transfers, as well as process development.  In this presentation we will review our progress on the implementation of said standards in the development of novel biopharmaceuticals, the challenges and benefits thereof.