Formulation and Fill for a Vaccine with Alum Adjuvant A Brief Case Study

摘要

The goal: Develop a CGMP formulation-fill process for a subunit vaccine-aluminum adjuvant complex. The challenge: To engineer a scaled-up process for vaccine-adjuvant suspension formulation and fill, ensuring a uniform fill per dose as well as a sterile product. The outcome: Florida Biologies scientists successfully developed the manufacturing, formulation-fill process and test methods. The process was conducted successfully in a scaled-down engineering run and at full scale, and 2,500 vials were tested, released, and shipped to the clinic on time.