Outsourcing Biologics Stability Programs:Points to Consider

摘要

As the pipeline of biologies continues to grow, biopharmaceutical organizations are outsourcing an increasing number of stability studies. Careful consideration must be given when choosing a partner for these programs due to their inherent complexity. Several key points to consider, including capability, capacity, protocol development, and project management, are discussed here. According to ICH Q1A (R2), "The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions." In the case of biologies, ICH Q5C states, "The evaluation of stability may necessitate complex analytical methodologies. Assays for biological activity, where applicable, should be part of the pivotal stability studies. Appropriate physicochemical, biochemical, and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program whenever purity and molecular characteristics of the product permit use of these methodologies."