How Can You Ensure Successful Late-Phase Development And Launch Of Your Biologic Drug Product?

By Dr. Claudia Müller, Head of Formulation Development, Dr. Heiko Nalenz, Head of Process Development, and Dr. Roman Mathaes, Head of Pharmaceutical Services

There are many considerations during late-phase development, such as those necessary to fulfill regulatory requirements. For example, in contrast to an IND, a marketing authorization must contain justification for the formulation composition, e.g., what is the function of the excipient, and why was it added at the chosen concentration? The overall choice of excipients for parenteral formulations is limited and therefore needs to be evaluated on a case-by-case basis with a specific focus on the impact the excipients have on other aspects of product development, such as safety and regulatory.

For example, an excipient successfully used for subcutaneous administration may not be safe for intravitreal administration, so additional safety data may need to be generated. Another example is when a higher than usual concentration of a standard excipient in the formulation is required for stabilization [recording cut out). If the required amount of the active results into a dose level outside of the established safety data for the excipient, additional safety data must be evaluated. In a third example, methionine is added to the formulation and claimed as an antioxidant. The dossier should contain data that shows stability and oxidation of the molecule with and without methionine. Additionally, the choice of methionine as an antioxidant will have an impact on the analytical drug product control strategy, as it may be necessary to monitor the concentration of methionine and its oxidation products throughout stability and shelf life.

Download the full article to learn more about other considerations that must be kept in mind during late-phase development as well as how to de-risk the path to market using a holistic development strategy.